Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study

Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).

Start Date01 Jun 2024

Sponsor / Collaborator

Geisinger Clinic

[+1]

NCT05387798

/ WithdrawnPhase 3

A Phase 3, Open-label Extension Study to Assess the Safety, Tolerability, and Efficacy of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome

This is a Phase 3 open-label extension (OLE) study in patients diagnosed with Prader-Willi Syndrome (PWS) who completed the Maintenance Period of the randomized, placebo-controlled Phase 2/3 study SCOUT-015.
The primary objective of this study is to assess the long-term safety and tolerability of RAD011.

Start Date01 Jan 2023

Sponsor / Collaborator

Radius Pharmaceuticals, Inc.

NCT05098509

/ TerminatedPhase 2/3

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of RAD011 (Cannabidiol Oral Solution) for the Treatment of Patients With Prader- Willi Syndrome

This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011 in order to select 1 or 2 dose level(s) for further evaluation in the Phase 3 part of the study. In Phase 3, the primary objective was to assess the effect of RAD011 on hyperphagia-related behavior in participants with PWS.

Start Date13 Apr 2022

Sponsor / Collaborator

Radius Pharmaceuticals, Inc.

100 Clinical Results associated with Radius Health, Inc.

0 Patents (Medical) associated with Radius Health, Inc.

Literatures (Medical) associated with Radius Health, Inc.

15 Mar 2025·JOURNAL OF BONE AND MINERAL RESEARCH

Bone turnover markers predict changes in bone mineral density in men treated with abaloparatide: results from the abaloparatide for the treatment of men with osteoporosis (ATOM) study

Article

Author: Brown, Jacques P ; Binkley, Neil ; Wang, Yamei ; Eastell, Richard ; Adler, Robert A ; Kendler, David ; Lewiecki, E Michael ; Orwoll, Eric S ; Mitlak, Bruce H

Abstract:

Early increases in bone turnover markers (BTMs) in response to anabolic therapy correlate with 18-mo BMD increases in postmenopausal women with osteoporosis; however, this relationship has not been assessed in men. In this analysis, the correlation between changes from baseline in fasting intact serum procollagen type I N propeptide (PINP) and serum CTX at 1, 3, 6, and 12 mo and percent increase from baseline in BMD at 12 mo in men from the randomized phase 3 ATOM study (NCT03512262) were evaluated using Pearson’s correlation coefficients. The uncoupling index (UI), a measure of the balance between markers of bone formation (PINP) and bone resorption (CTX), with positive UI favoring bone formation, was calculated. Results in men were compared to 12-mo results for women from the ACTIVE study using the z score test after Fisher’s Z transformation. In abaloparatide-treated men, PINP increases at 1 mo (r = 0.485), 3 mo (r = 0.614), 6 mo (r = 0.632), and 12 mo (r = 0.521) were highly correlated (p < .0001) with 12-mo LS BMD increases. The mean UI for abaloparatide-treated men was greater than placebo as early as 1 mo (2.26 vs −0.25). At month 3, the mean UI for men was greater (1.32) than for women (0.88) (p < .001). There was a significant correlation between 3-mo UI and LS BMD at 12 mo in both men (r = 0.453; p < .001) and women (r = 0.252; p < .01). UI at months 6 and 12 were also significantly correlated with 12-mo LS BMD in men and women, but the correlation was stronger in men than women. These data support that early changes in BTMs in men treated with abaloparatide are associated with subsequent changes in BMD similar to what has been reported in women.

01 Feb 2025·Endocrine Practice

Comparative Effectiveness of Abaloparatide and Teriparatide in Women 50 Years of Age and Older: Update of a Real-World Retrospective Analysis

Article

Author: Mitlak, Bruce H ; Rizzoli, René ; Reginster, Jean-Yves ; Wang, Yamei ; Chiodo, Joseph ; Curtis, Jeffrey R ; Mitlak, Bruce H. ; Cortet, Bernard ; DeSapri, Kristi T ; LaBaume, Clayton T. ; Tabatabai, Laila ; LaBaume, Clayton T ; Curtis, Jeffrey R. ; DeSapri, Kristi T. ; Cosman, Felicia

BACKGROUND:

Abaloparatide and teriparatide are osteoanabolic treatments indicated for postmenopausal women and men with osteoporosis at high risk of fracture. In the Abaloparatide Comparator Trial In Vertebral Endpoints study, bone mineral density improvements were significantly greater with abaloparatide compared to teriparatide at the total hip and femoral neck. We conducted a retrospective claims study to examine the incidences of hip and nonvertebral fractures and cardiovascular events in women aged ≥50 years initiating abaloparatide or teriparatide therapy, expanding on a previous retrospective claims study.

METHODS:

This retrospective observational study used anonymized claims data from ICON's Symphony Health, PatientSource for women aged ≥ 50 years with ≥ 1 prescription fill for abaloparatide or teriparatide. The index date was the date of the initial prescription dispensed. Times to first hip fracture, nonvertebral fracture, and serious cardiovascular event were compared between logistic regression-based propensity score-matched cohorts and in predefined subgroups by age, prior antiresorptive use, and prior fracture using Cox proportional hazards models.

RESULTS:

Patients (21 676 per cohort) were well matched on 73 baseline parameters. Forty-five percent of patients in the abaloparatide arm and 47% in the teriparatide arm were exposed to treatment for longer than 12 months. Over 18 months (+ 30 days follow-up), 245 (1.1%) and 296 (1.4%) women in the abaloparatide and teriparatide cohorts, respectively, had a hip fracture (HR [95% CI] 0.83 [0.70, 0.98]; P = .027); 947 (4.4%) and 1078 (5.0%) had a nonvertebral fracture (0.88 [0.80, 0.96]; P = .003). There were no significant treatment-subgroup interactions (P ≥ .2). Cardiovascular events were similar between groups.

CONCLUSIONS:

There were significantly lower rates of hip and nonvertebral fractures with abaloparatide compared to teriparatide, which were consistent across subgroups. No differences in cardiovascular safety were noted between cohorts.

01 Sep 2024·JBMR Plus

Healing sequelae following tooth extraction and dental implant placement in an aged, ovariectomy model

Article

Author: Mitlak, Bruce ; Sugai, James V ; Giannobile, William V ; Larsson, Lena ; Lanske, Beate ; Shiba, Takahiko ; Latimer, Jessica M ; Maekawa, Shogo ; Fretwurst, Tobias ; Chen, Michael ; Kostenuik, Paul

Abstract:

At present, a lack of consensus exists regarding the clinical impact of osteoporosis on alveolar bone metabolism during implant osseointegration. While limited preclinical and clinical evidence demonstrates a negative influence of osteoporosis on dental extraction socket healing, no preclinical studies offer data on the results of implant placement in 6-mo-old, ovariectomized (OVX) Sprague–Dawley rats. This study aimed to investigate the outcomes of dental tooth extraction socket healing and implant placement in a rodent model of osteoporosis following daily vehicle (VEH) or abaloparatide (ABL) administration. Micro-CT and histologic analysis demonstrated signs of delayed wound healing, consistent with alveolar osteitis in extraction sockets following 42 d of healing in both the VEH and ABL groups. In a semiquantitative histological analysis, the OVX-ABL group demonstrated a tendency for improved socket regeneration with a 3-fold greater rate for moderate socket healing when compared to the OVX-VEH group (43% vs 14%), however, this finding was not statistically significant (p=.11). No significant differences were observed between vehicle and test groups in terms of implant outcomes (BMD and bone volume/total volume) at 14- and 21-d post-implant placement. Abaloparatide (ABL) significantly increased BMD of the femoral shaft and intact maxillary alveolar bone sites in OVX animals, demonstrating the therapeutic potential for oral hard tissue regeneration. The present model involving estrogen-deficiency-induced bone loss demonstrated an impaired healing response to dental extraction and implant installation.

124

News (Medical) associated with Radius Health, Inc.

03 Jan 2025

·www.pharmaindustrial-india.com

Pharmanovia Signs In-Licensing Deal for Osteoporosis Treatment with Radius Health

Pharmanovia has signed an exclusive in-licensing agreement with Radius Health, Inc for osteoporosis treatment, abaloparatide, which is marketed in the US as TYMLOS®. Under the terms of the agreement Pharmanovia will be responsible for clinical, regulatory and commercial activities across key markets in the Asia Pacific region, specifically China, Singapore, Thailand, Indonesia, Vietnam, Taiwan, Hong Kong, Malaysia, Macau and the Philippines. Abaloparatide is a human parathyroid hormone related peptide analogue indicated by the FDA for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. Abaloparatide is also indicated to increase bone density in men with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. “We are thrilled to expand our portfolio and bring to the Asia Pacific region such an important and innovative osteoporosis treatment. This deal recognises the strength of our commercial model in APAC, and China in particular, where we have one of the leading osteoporosis commercial platforms. With Tymlos® we will serve a broader patient population, providing osteoporosis solutions in the high, medium and low risk categories, further addressing unmet needs and meeting bone health challenges,” said James Burt, CEO, Pharmanovia. “This collaboration partners two companies that share a commitment to improving the lives of patients with osteoporosis. With Pharmanovia’s expertise in osteoporosis and their proven track record of success in these territories, we can look forward to significantly expanding access of abaloparatide to patients in need of osteoporosis treatment options,” said Scott Briggs, CEO, Radius Health.

License out/in

02 Jan 2025

·www.accesswire.com

Radius Pharmaceuticals Announces Licensing Agreement with Pharmanovia to Register and Commercialize Abaloparatide in China and Select Asia Pacific Territories

BOSTON, MA / ACCESSWIRE / January 2, 2025 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. (\"Radius\" or the \"Company\"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Pharmanovia the exclusive commercialization rights to abaloparatide, a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. The licensing agreement covers markets in the Asia Pacific region, specifically China, Singapore, Thailand, Indonesia, Vietnam, Taiwan, Hong Kong, Malaysia, Macau and the Philippines. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.\"We are very pleased to enter into a partnership with Pharmanovia with the goal of making abaloparatide available to patients in additional global markets,\" said Scott Briggs, Chief Executive Officer of Radius. \"This collaboration partners two companies that share a commitment to improving the lives of patients with osteoporosis. With Pharmanovia\'s expertise in osteoporosis and their proven track record of success in these territories, we can look forward to significantly expanding abaloparatide access to patients in need of osteoporosis treatment options.\"\"We are thrilled to expand our portfolio and bring to the Asia Pacific region such an important and innovative osteoporosis treatment,\" said James Burt, Chief Executive Officer of Pharmanovia. \"This deal recognizes the strength of our commercial model in APAC, and China in particular, where we have one of the leading osteoporosis commercial platforms.\"Under the terms of the Licensing Agreement, Radius would be eligible to receive an upfront payment as well as regulatory and commercial milestones plus tiered royalties on net sales.About Radius:Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius\' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company\'s presence in bone health.About Pharmanovia:Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by rediscovering, repurposing or re-engineering established medicines or by bringing to market novel medicines to improve patient outcomes and experiences. With a diverse and growing team in over 160 countries across the globe, we deliver high-quality solutions, ethically and sustainably, across our four core therapeutic areas - Endocrinology, Neurology, Cardiovascular and Oncology both in rare and established diseases or conditions.Contacts:Al Medwar: Senior Vice President, Business and Corporate Development, Radius Email: [email protected]SOURCE: Radius Health Related Documents:

Drug ApprovalLicense out/in

09 Dec 2024

·www.accesswire.com

Radius Pharmaceuticals Expands Abaloparatide Licensing Agreement with Theramex Granting Additional Commercialization Rights Including Mexico, Canada, South Africa, Israel, and Russia

BOSTON, MA / ACCESSWIRE / December 9, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Theramex the exclusive commercialization rights to ELADYNOS® (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, for Mexico, Canada, Israel, South Africa, and Russia. Theramex will also have the opportunity to commercialize ELADYNOS® in other agreed upon unpartnered regions. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.Under the License Agreement, Radius will receive an upfront and milestone payment plus tiered royalties."Theramex has been an excellent collaborative partner, and we are very pleased to expand our abaloparatide partnership to include additional important global markets," said Scott Briggs, Chief Executive Officer of Radius. "Radius is committed to making abaloparatide accessible to patients, and the expansion of our existing partnership helps provide access to additional patients in need of osteoporosis treatment options.""Following the launch of abaloparatide in Europe, we are excited to bring this innovative product to more patients globally and drive further growth through our direct markets and our commercial partnerships. This agreement expands our successful relationship with Radius, and we look forward to continuing our close collaboration," said Rob Stewart, Chief Executive Officer of Theramex.In addition to these new territories, Theramex will continue to commercialize and distribute ELADYNOS® on an exclusive basis in the European Economic Area, the United Kingdom, Australia, and Brazil. ELADYNOS® received approval in the European Economic Area in December 2022 and Australia in November 2024 and has been launched in select countries.About Radius:Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health.About Theramex:Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering osteoporosis, contraception, fertility, menopause and uterine health. Theramex's commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex's vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.Contacts:Al Medwar: Senior Vice President, Business and Corporate Development, Radius Email: [email protected]Edward Rees: Chief Corporate Development Officer, TheramexEmail: to [email protected]SOURCE: Radius Health

Drug ApprovalLicense out/in

100 Deals associated with Radius Health, Inc.

100 Translational Medicine associated with Radius Health, Inc.

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Pipeline

Pipeline Snapshot as of 04 Aug 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 1

NDA/BLA

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Abaloparatide ( PTH1R )	Osteoporosis, Postmenopausal More	Approved
Alendronate Sodium	Osteoporosis, Postmenopausal More	Approved
RAD-140 ( AR )	Breast Cancer More	Phase 1
Elacestrant hydrochloride ( ERα )	Vasomotor symptom More	Discontinued
Cannabidiol	Prader-Willi Syndrome More	Discontinued

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