In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.

Start Date01 Apr 2025

Sponsor / Collaborator

The General Hospital Corp.

NCT06303284 / Not yet recruitingPhase 1/2

Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT

As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs.
There is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications.
The proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed.
This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Calgary

NCT06264609 / Enrolling by invitationPhase 4IIT

Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover - Follow Up Study

Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.
Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.
Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment.

Start Date01 Feb 2024

Sponsor / Collaborator

University of Kentucky

100 Clinical Results associated with Teriparatide(Eli Lilly)

100 Translational Medicine associated with Teriparatide(Eli Lilly)

100 Patents (Medical) associated with Teriparatide(Eli Lilly)

2,366

Literatures (Medical) associated with Teriparatide(Eli Lilly)

01 Dec 2024·Molecular biology reports

Exploring epigenetic strategies for the treatment of osteoporosis

Review

Author: Kim, Kyunghwan ; Yi, Sun-Ju ; Lim, Jaeho

The worldwide trend toward an aging population has resulted in a higher incidence of chronic conditions, such as osteoporosis. Osteoporosis, a prevalent skeletal disorder characterized by decreased bone mass and increased fracture risk, encompasses primary and secondary forms, each with distinct etiologies. Mechanistically, osteoporosis involves an imbalance between bone resorption by osteoclasts and bone formation by osteoblasts. Current pharmacological interventions for osteoporosis, such as bisphosphonates, denosumab, and teriparatide, aim to modulate bone turnover and preserve bone density. Hormone replacement therapy and lifestyle modifications are also recommended to manage the condition. While current medications offer therapeutic options, they are not devoid of limitations. Recent studies have highlighted the importance of epigenetic mechanisms, including DNA methylation and histone modifications, in regulating gene expression during bone remodeling. The use of epigenetic drugs, or epidrugs, to target these mechanisms offers a promising avenue for therapeutic intervention in osteoporosis. In this review, we comprehensively examine the recent advancements in the application of epidrugs for treating osteoporosis.

01 Oct 2024·BONE

Effects of daily teriparatide, weekly high-dose teriparatide, or bisphosphonate on cortical and trabecular bone of vertebra and proximal femur in postmenopausal women with fragility fracture: Sub-analysis by quantitative computed tomography from the TERABIT study

Article

Author: Yamada, Shuta ; Ota, Shingo ; Kono, Mika ; Mitsumizo, Kazutaka ; Okazaki, Narihiro ; Fukuda, Toru ; Era, Makoto ; Doi, Mitsuru ; Watanabe, Kounosuke ; Yokota, Kazuaki ; Takahashi, Ryosuke ; Chiba, Ko ; Yonekura, Akihiko ; Yabe, Yoshihiro ; Shiraishi, Kazuteru ; Osaki, Makoto ; Sato, Shuntaro ; Iida, Takeshi ; Kondo, Choko ; Michikoshi, Yasue ; Fukushima, Kaisho

PURPOSE:

The effects of daily teriparatide (D-PTH, 20 μg/day), weekly high-dose teriparatide (W-PTH, 56.5 μg/week), or bisphosphonate (BP) on the vertebra and proximal femur were investigated using quantitative computed tomography (QCT).

METHODS:

A total of 131 postmenopausal women with a history of fragility fractures were randomized to receive D-PTH, W-PTH, or bisphosphonate (oral alendronate or risedronate). QCT were evaluated at baseline and after 18 months of treatment.

RESULTS:

A total of 86 participants were evaluated by QCT (Spine: D-PTH: 25, W-PTH: 21, BP: 29. Hip: PTH: 22, W-PTH: 21, BP: 32. Dropout rate: 30.5 %). QCT of the vertebra showed that D-PTH, W-PTH, and BP increased total vBMD (+34.8 %, +18.2 %, +11.1 %), trabecular vBMD (+50.8 %, +20.8 %, +12.2 %), and marginal vBMD (+20.0 %, +14.0 %, +11.5 %). The increase in trabecular vBMD was greater in the D-PTH group than in the W-PTH and BP groups. QCT of the proximal femur showed that D-PTH, W-PTH, and BP increased total vBMD (+2.8 %, +3.6 %, +3.2 %) and trabecular vBMD (+7.7 %, +5.1 %, +3.4 %), while only W-PTH and BP significantly increased cortical vBMD (-0.1 %, +1.5 %, +1.6 %). Although there was no significant increase in cortical vBMD in the D-PTH group, cortical bone volume (BV) increased in all three treatment groups (+2.1 %, +3.6 %, +3.1 %).

CONCLUSIONS:

D-PTH had a strong effect on trabecular bone of vertebra. Although D-PTH did not increase cortical BMD of proximal femur, it increased cortical BV. W-PTH had a moderate effect on trabecular bone of vertebra, while it increased both cortical BMD and BV of proximal femur. Although BP had a limited effect on trabecular bone of vertebra compared to teriparatide, it increased both cortical BMD and BV of proximal femur.

01 Oct 2024·Orthopaedic Surgery

Comparing the Efficacy of Antiosteoporotic Drugs in Preventing Periprosthetic Bone Loss Following Total Hip Arthroplasty: A Systematic Review and Bayesian Network Meta‐Analysis

Review

Author: Chen, Lei ; Lu, Yichen ; Tang, Yi ; Chen, Guoqian ; Jin, Zhaokai ; Tong, Peijian ; Lv, Shuaijie ; Xu, Taotao

Background:

Periprosthetic bone loss is a well‐known phenomenon following total hip arthroplasty (THA). However, the choice of drugs for prevention remains controversial. Therefore, the aim of this study was to determine the best drug to treat periprosthetic bone loss by comparing changes in bone mineral density (BMD) at different times after THA.

Methods:

A comprehensive search of five databases and two clinical trial registration platforms was undertaken from their inception through to August 31, 2023 to identify eligible randomized controlled trials. A Bayesian network meta‐analysis (NMA) was carried out for calculating the standardized mean difference (SMD) and the surface under cumulative ranking curve (SUCRA) of the BMD in calcar (Gruen zone 7) at 6 months, 12 months, and 24 months and over.

Results:

Twenty‐nine trials involving 1427 patients and 10 different interventions were included. The results demonstrated that at 6 months, denosumab had the highest ranking (SUCRA = 0.90), followed by alendronate (SUCRA = 0.76), and zoledronate (SUCRA = 0.73). At 12 months, clodronate ranked highest (SUCRA = 0.96), followed by denosumab (SUCRA = 0.84) and teriparatide (SUCRA = 0.82). For interventions with a duration of 24 months and over, denosumab had the highest SUCRA value (SUCRA = 0.96), followed by raloxifene (SUCRA = 0.90) and zoledronate (SUCRA = 0.75).

Conclusion:

Investigating the existing body of evidence revealed that denosumab demonstrates potential as an intervention of superior efficacy at the three specifically examined time points. However, it remains crucial to conduct further research to confirm these findings and determine the most effective treatment strategy.

News (Medical) associated with Teriparatide(Eli Lilly)

10 Sep 2024

·www.prnewswire.com

Adcentrx Therapeutics Announces Formation of Scientific Advisory Board

Company appoints Mike Varney, Ph.D. and Kerry Blanchard, M.D., Ph.D. as founding SAB members SAN DIEGO and SHANGHAI, Sept. 10, 2024 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company focused on accelerating breakthroughs in developing protein conjugate therapeutics for cancer and other life-threatening diseases, today announces the formation of its Scientific Advisory Board (SAB) to support the advancement of its innovative Antibody-Drug Conjugate (ADC) technology platform and pipeline, including ADRX-0706, a Nectin-4 targeting ADC therapeutic currently being evaluated in a Phase 1a/b clinical trial. Continue Reading The inaugural SAB will work closely with Adcentrx's executive team to provide strategic guidance and expert insights to advance its mission of creating the best therapies to treat serious and life-threatening diseases. Formation of SAB with founding members Dr. Varney and Dr. Blanchard represents significant advancement for Adcentrx. Post this "The establishment of our SAB represents a significant advancement for Adcentrx as we progress our ADC portfolio," said Hui Li, Ph.D., President and CEO of Adcentrx. "We are privileged to welcome these exceptional scientific leaders to the Adcentrx team, and their combined expertise and guidance will be instrumental in shaping our future research and clinical development." The Founding Members of the Adcentrx SAB are: Mike Varney, Ph.D. Dr. Varney brings extensive experience in drug discovery and development, having served as Executive Vice President, Head of Genentech Research and Early Development, where he was responsible for all research activities. During his tenure at Genentech, he oversaw the discovery and development of multiple innovative therapies, including the approved cancer treatments Erivedge® and Cotellic®. Earlier in his career, Dr. Varney pioneered the use of protein-structure based drug design at Agouron Pharmaceuticals. This innovative approach led to the discovery and market approval of HIV protease inhibitor, Viracept®. After Agouron's acquisition by Warner Lambert and subsequently by Pfizer, he served as Vice President of Drug Discovery at Pfizer Global Research & Development, leading research initiatives across oncology, virology, diabetes, and ophthalmology at the La Jolla site. Dr. Varney holds a Ph.D. in Organic Synthesis from the California Institute of Technology and a B.S. in Chemistry from the University of California, Los Angeles, and was an American Cancer Society Postdoctoral Research Fellow at Columbia University. Kerry Blanchard, M.D., Ph.D. Dr. Blanchard has been a drug hunter and entrepreneur for more than four decades in the US and Asia. He is currently cofounder, Chairman, and CEO of Perpetual Medicines, a peptide therapeutics/computational AI platform company. Previously, he was the CEO of Everest Medicines, Chief Science Officer at Innovent Biologics, Senior Vice President of Lilly China Drug Development and External Innovation, and a senior executive at Eli Lilly and Company. He was a member of the board for Lilly China and Zymeworks Inc., and was the co-chairman of the Lilly Asia Ventures Investment Committee. Prior to joining Lilly in 2000, he was a tenured Professor of Medicine and Biochemistry & Molecular Biology at Louisiana State University Health Sciences Center in Shreveport, LA. Dr. Blanchard has brought four medicines to the market from his own research including Verzenio®, a CDK 4/6 inhibitor, and, his development teams in China have had more than 30 approved medicines in Asia including Trodelvy®, Trulicity®, Byetta®, Forteo®, and Tyvyt®. At Innovent and Everest, Dr. Blanchard successfully raised over $2 billion to support and expand their pipelines. His track record in accelerating clinical development and navigating regulatory landscapes will significantly enhance Adcentrx's strategic initiatives and global expansion. Dr. Blanchard received his M.D. and Ph.D. in Biochemistry from Indiana University and completed his residency and fellowships at Brigham and Women's Hospital, Dana Farber Cancer Institute, and Harvard Medical School. About Adcentrx Therapeutics Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of i-Conjugation™, an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. In addition to ADRX-0706, Adcentrx is developing a robust pipeline of ADCs with first-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit . Contact Information: Investor Relations [email protected] SOURCE Adcentrx Therapeutics

Executive ChangeAcquisitionADC

19 Aug 2024

·www.echemi.com

Sirnaomics' Peptide Business Explodes! Raw Material Exports Increase by 97.51% in the First Half, Leading the Way in a $20 Billion Blue Ocean Market

Sirnaomics, a company that has been deeply involved in the peptide field for over 20 years, achieved significant growth in the export of peptide APIs in the first half of the year, with a year-on-year growth rate of 97.51%, showing its strong development momentum. Although the company experienced violent fluctuations in the capital market, its profound accumulation in the peptide field and stable performance growth have made it an important force in the industry. Sirnaomics' three core businesses - innovative drug CDMO services for peptides, peptide formulations business, and peptide API business - have collectively driven growth in performance. Of these, the API business has performed particularly well, with overseas sales growing by 97.51% year-on-year, becoming one of the main driving forces for profit growth. Peptide drugs are a type of emerging drugs that lie between small molecule chemical drugs and protein drugs, with advantages such as high activity, low toxicity, and quality control. They are suitable for solving complex diseases that are difficult to address with small molecule chemical drugs. The global peptide drug market size has already exceeded $20 billion, accounting for about 2% of the total pharmaceutical market, but it has maintained a high growth rate of around 10%. Some of the most popular peptide drugs include GLP-1 analogues, used to treat type 2 diabetes, such as liraglutide and exenatide, with sales exceeding $3 billion. Growth hormone and growth hormone-like substances are used to treat diseases caused by disorders in growth hormone secretion, with global sales of approximately $2.8 billion and $2.4 billion, respectively. LHRH agonist analogs are used to treat prostate cancer, postmenopausal breast cancer, etc., with global sales of approximately $4.8 billion. Other popular peptide drugs include teriparatide and linagliptin. In the Chinese market, sales of peptide drugs are also growing rapidly. They reached RMB 63.05 billion in 2017, mainly due to the large population base, accelerating aging, and a large number of cancer and chronic disease patients. The market demand for this will continue to expand, and there is still significant growth potential for peptide drugs. The peptide drug market is currently in a period of rapid development, and is expected to exceed $6 billion in the next 10 years. As synthetic technology advances and new indications are developed, peptide drugs will play an increasingly important role in the treatment of cancer, diabetes, and rare diseases. In recent years, as the peptide drug market has continued to expand, demand for upstream raw materials has soared. Sirnaomics has accumulated years of experience in synthesis and modification technologies, and has mastered several core technologies, solving technical bottlenecks for the production of multiple peptide raw materials. Currently, its API products have been sold to countries and regions such as Europe, the United States, and South Korea, and it has established cooperative relationships with many well-known pharmaceutical enterprises at home and abroad. In the future, Sirnaomics will continue to increase its R&D investment, enhance its peptide drug R&D capabilities and optimize production processes. It will also accelerate the implementation progress of its ongoing construction projects to seize market development opportunities. As its future capacity gradually releases, Sirnaomics is expected to drive sustained growth in its performance.

PDC

15 Aug 2024

·pmlive.com

NICE recommends Theramex’s Eladynos to treat bone disease after menopause

The National Institute for Health Care and Research has recommended Theramex’s Eladynos (abaloparatide) as an option for treating bone disease after menopause. Available on the NHS in England in three months, the drug is set to benefit more than 14,000 people in the UK who are seeking treatment for osteoporosis after menopause, if there is a very high risk of fracture. Osteoporosis, a bone disease that affects 3.8 million people in the UK, develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and bone density reduces, making broken bones more common. Other treatments for the disease include bisphosphonates such as alendronic acid and ibandronic acid, Eli Lilly’s selective oestrogen receptor modulator, Evista (raloxifene), parathyroid hormone treatments including teriparatide, and biological medicines including Amgen’s Prolia (denosumab) and Amgen/UCB’s Evenity (romosozumab). NICE’s decision was based on patients descriptions of how debilitating osteoporosis can be and how it all impacts day-to-day life, impairing mental and physical health. Theramex’s Eladynos is designed to increase bone density by stimulating the cells that produce new bone while also reducing the risk of fracture, providing an alternative for patients who have not responded to or cannot tolerate usual treatment options. Proven to be more clinically and cost-effective, the alternative treatment option comes as a pre-filled pen that is injected into the muscle through the skin. Prior to this, in March, Bayer shared positive long-term results from the late-stage OASIS 3 study, which supported the use of its investigational non-hormonal menopause drug, elinzanetant, to treat moderate-to-severe vasomotor symptoms (VMS), such as hot flashes, which are reported by up to 80% of women during the menopausal transition. In April, a Canadian study published in Neurology revealed that early menopause and a higher risk of cardiovascular disease could be linked to cognitive decline later in life.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Teriparatide(Eli Lilly)

External Link

KEGG	Wiki	ATC	Drug Bank
D06078	Teriparatide(Eli Lilly)	H05AA02	DB06285

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Glucocorticoid-induced osteoporosis	AU	Eli Lilly Australia Pty Ltd.	22 May 2003
Osteoporosis, Postmenopausal	AU	Eli Lilly Australia Pty Ltd.	22 May 2003
Primary osteoporosis	AU	Eli Lilly Australia Pty Ltd.	22 May 2003
Osteoporosis	US	Eli Lilly & Co.	26 Nov 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Femoral Fractures	Phase 3	CA	Eli Lilly & Co.	01 Jul 2013
Femoral Neck Fractures	Phase 3	US	Eli Lilly & Co.	01 Jan 2012
Femoral Neck Fractures	Phase 3	BE	Eli Lilly & Co.	01 Jan 2012
Femoral Neck Fractures	Phase 3	HR	Eli Lilly & Co.	01 Jan 2012
Femoral Neck Fractures	Phase 3	FR	Eli Lilly & Co.	01 Jan 2012
Femoral Neck Fractures	Phase 3	DE	Eli Lilly & Co.	01 Jan 2012
Femoral Neck Fractures	Phase 3	GR	Eli Lilly & Co.	01 Jan 2012
Femoral Neck Fractures	Phase 3	HU	Eli Lilly & Co.	01 Jan 2012
Femoral Neck Fractures	Phase 3	IN	Eli Lilly & Co.	01 Jan 2012
Femoral Neck Fractures	Phase 3	NL	Eli Lilly & Co.	01 Jan 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FDA_CDER Manual	Not Applicable	Glucocorticoid-induced osteoporosis	428	Teriparatide	wdcnvhleqr(jkwcfsyqvv) = yvjfpemeby ieqzoxahgw (swluqktdnx ) View more	Positive	04 Jun 2024
				prednisone or equivalent	-
FDA_CDER Manual	Not Applicable	Hypogonadal osteoporosis \| Primary osteoporosis	-	Teriparatide	ugtbdbldme(aadzibbuct) = dvyvdxrnnc vxdrilwjcv (jrbxdsuhfz ) View more	Positive	04 Jun 2024
				Placebo	ugtbdbldme(aadzibbuct) = mdcfuncxsx vxdrilwjcv (jrbxdsuhfz ) View more
FDA_CDER Manual	Not Applicable	Osteoporosis, Postmenopausal	1,637	Teriparatide	frlffewrei(wgmotoolql) = phorebbvib nhbixtqbsr (vtburxbvqi ) View more	Positive	04 Jun 2024
				Placebo	frlffewrei(wgmotoolql) = jzssldytdr nhbixtqbsr (vtburxbvqi ) View more
EULAR2022	Not Applicable	-	25	Teriparatide + Denosumab	dzgyfkxxxr(xdybktheuw) = lggvbyrnvm ifmglwduoa (fhagebldrv, 3.6%) View more	-	01 Jun 2022
				Denosumab alone	dzgyfkxxxr(xdybktheuw) = ibjmwsycrx ifmglwduoa (fhagebldrv, 3.6%) View more
NCT01440803 (Pubmed \| J Clin Endocrinol Metab)	Phase 2	Osteoporosis, Postmenopausal	41	Teriparatide 20 mcg	hacgpdrjuk(uadpctfnor) = kxrtyzzqve cqydsdsxzt (fpamrhevfh, 3.83 - 7.19) View more	Positive	01 Oct 2020
				Placebo	hacgpdrjuk(uadpctfnor) = mexhfwywns cqydsdsxzt (fpamrhevfh, -0.73 to 3.83)
NCT02023411 (CTgov)	Phase 2	Diabetes Mellitus \| Arthropathy, Neurogenic	20	Teriparatide (Teriparatide)	wplbohrdrv(gyuoteghms) = owcwrfjgem nunqxatttv (dyhgotozlg, tcpopjmrub - dejllstnug) View more	-	16 Sep 2020
				Placebo (Placebo)	wplbohrdrv(gyuoteghms) = zwmziocycd nunqxatttv (dyhgotozlg, laldgztkqo - luzhnrhhzx) View more
P0903 (ERA2020)	Not Applicable	Chronic Kidney Diseases	39,128	Osteoporosis medications (bisphosphonates, raloxifene, teriparatide, or denosumab)	lzhwgkggrf(uphhwomzxj) = hsejdydjim dyjmckcenv (cmnsneshqp ) View more	Negative	06 Jun 2020
P0902 (ERA2020)	Not Applicable	iPTH \| BAP \| iP1NP ... View more	5	Teriparatide 20 µg	zgrsycezqf(cwokjwwwpt) = 1.2±1.5% rfesfkxobi (wozhspziik ) View more	Positive	06 Jun 2020
NCT01709110 (VERO, Pubmed)	Phase 4	postmenopausal disorder	1,360	Teriparatide	xlrptzqnjo(pgtaupdmna) = qqcyrbiuyz petyuskdzl (zhysmbypvo )	-	01 Jun 2020
NCT01709110 (VERO, Pubmed \| Osteoporos Int)	Phase 4	Osteoporotic Fractures \| Osteoporosis, Postmenopausal \| Spinal Fractures	1,360	Teriparatide	oatxwrctix(hnxsfezedn): HR = 0.4 (95% CI, 0.23 - 0.68), P-Value = 0.001	Positive	30 May 2020
				Risedronate

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