Osteoporosis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Phase 3 Multicenter Study to Evaluate the Safety and Efficacy of Abaloparatide-SC for the Treatment of Men With Osteoporosis
Verified date | April 2023 |
Source | Radius Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
Status | Completed |
Enrollment | 228 |
Est. completion date | September 8, 2021 |
Est. primary completion date | August 17, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 85 Years |
Eligibility | Key Inclusion Criteria - Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism. - The participant has a BMD T-score based on female or male reference range (depending on date of enrollment) as assessed by the central imaging vendor of = -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA) or = -1.5 and with radiologic evidence of vertebral fracture or a documented history of low-trauma nonvertebral fracture sustained in the past 5 years. Men older than 65 years may be enrolled if they have a BMD T-score = -2.0 even if they do not meet the fracture criteria. - Normal medical history, physical examination, including vital signs, and body mass index. - Hypogonadal participants whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study. - Laboratory tests within the normal range including serum calcium (albumin-corrected), parathyroid hormone, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone values. Key Exclusion Criteria - Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal BMD, defined as having at least 2 radiologically evaluable vertebrae within L1-L4. - A BMD T-score of =-3.5 at the total hip, femoral neck, or lumbar spine based on female or male reference range (depending on date of enrollment). - Unevaluable hip BMD or participants who have undergone bilateral hip replacement. - Fragility fracture within the prior twelve months. - History of severe vertebral fracture or >2 moderate vertebral fractures. - History of bone disorders (for example, Paget's disease) other than osteoporosis. - participant with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement. - History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine. - History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the participant. - History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo- or hyperparathyroidism or malabsorptive syndromes within the past year. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda ospedaliera universitaria Careggi | Florence | Tuscany |
Italy | Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte | Siena | Toscana |
Italy | Azienda ospedaliera universitaria integrata di verona(AOUI) | Verona | |
Poland | ClinicMed Daniluk, Nowak Sp.j. | Bialystok | |
Poland | Zdrowie Osteo-Medic s.c. Lidia I Artur Racewicz, Agnieszka I Jerzy Supronik | Bialystok | Podlaskie |
Poland | Krakowskie Centrum Medyczne Sp. z o.o. | Kraków | Malopolskie |
Poland | Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci | Lódz | |
Poland | ETG Siedlce | Siedlce | |
Poland | Lubelskie Centrum Diagnostyczne | Swidnik | |
Poland | NZOZ Nasz Lekarz | Torun | |
Poland | Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warszawa | Mazowieckie |
Poland | Synexus Polska Sp z o.o Oddzial we Wroclawiu | Wroclaw | |
United States | New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | PMG Research of Cary, LLC | Cary | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | The University of Chicago | Chicago | Illinois |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Altoona Center For Clinical Research | Duncansville | Pennsylvania |
United States | Center For Advanced Research & Education | Gainesville | Georgia |
United States | Panorama Orthopedics & Spine Center | Golden | Colorado |
United States | Marin Endocrine Care & Research, Inc. | Greenbrae | California |
United States | Indago Research & Health Center, Inc. | Hialeah | Florida |
United States | Centex Studies, Inc. | Houston | Texas |
United States | University of Wisconsin Osteoporosis Clinical Research Program | Madison | Wisconsin |
United States | Centex Studies, Inc | McAllen | Texas |
United States | Baptist Diabetes Associates, Pa | Miami | Florida |
United States | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia |
United States | Meridian Clinical Research | Savannah | Georgia |
United States | Alta California Medical Group | Simi Valley | California |
United States | SUNY Upstate Medical University | Syracuse | New York |
United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
United States | MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) | Washington | District of Columbia |
United States | PMG Research of Wilmington, LLC | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Radius Health, Inc. |
United States, Italy, Poland,
Dempster DW, Cosman F, Parisien M, Shen V, Lindsay R. Anabolic actions of parathyroid hormone on bone. Endocr Rev. 1993 Dec;14(6):690-709. doi: 10.1210/edrv-14-6-690. No abstract available. Erratum In: Endocr Rev 1994 Apr;15(2):261. — View Citation
Mannstadt M, Juppner H, Gardella TJ. Receptors for PTH and PTHrP: their biological importance and functional properties. Am J Physiol. 1999 Nov;277(5):F665-75. doi: 10.1152/ajprenal.1999.277.5.F665. — View Citation
Rizzoli R, Bonjour JP, Ferrari SL. Osteoporosis, genetics and hormones. J Mol Endocrinol. 2001 Apr;26(2):79-94. doi: 10.1677/jme.0.0260079. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. | Baseline, Month 12 | |
Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. | Baseline, Month 12 | |
Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 12 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. | Baseline, Month 12 | |
Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Lumbar Spine BMD was assessed by DXA scans evaluated by a central imaging laboratory. Lumbar spine scans included L1 through L4. Positive changes from baseline indicate improvement in bone health. | Baseline, Month 6 | |
Secondary | Percent Change in Total Hip BMD From Baseline at Month 6 | Total hip BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. | Baseline, Month 6 | |
Secondary | Percent Change From Baseline in Femoral Neck BMD at Month 6 | Femoral neck BMD was assessed by DXA scans evaluated by a central imaging laboratory. Positive changes from baseline indicate improvement in bone health. | Baseline, Month 6 | |
Secondary | Percent Change From Baseline in Ultra-Distal Radius BMD at Month 12 | Ultra-distal radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. | Baseline, Month 12 | |
Secondary | Percent Change From Baseline in Distal One-third Radius BMD at Month 12 | Distal one-third radius BMD was assessed by DXA scans. Positive changes from baseline indicate improvement in bone health. | Baseline, Month 12 | |
Secondary | Percent Change From Baseline in Serum Procollagen Type I N-terminal Propeptide (s-PINP) at Month 12 | Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone. | Baseline, Month 12 | |
Secondary | Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) at Month 12 | Blood samples were taken to measure s-CTX. Elevated levels of s-CTX indicate increased bone resorption (bone loss). | Baseline, Month 12 | |
Secondary | Number of Participants With New Clinical Fractures | Radiological evaluations were performed to identify any new clinical fractures (occurring after the screening visit). | Baseline through Month 12 | |
Secondary | Percent of Participants With Change in Disease Status | The percentage of participants converting from the categories of osteoporosis to osteopenia or from osteopenia to normal at End of Treatment (Month 12) was assessed. Osteoporosis was defined as lumbar spine or total hip BMD T-score = -2.5. Osteopenia was defined as one of the following:
Lumbar spine > -2.5 and total hip BMD T-score > -2.5 and < -1.0 Lumbar spine > -2.5 and < -1.0 and total hip BMD T-score > -2.5 Normal was defined as lumbar spine and total hip BMD T-score = -1.0. |
Baseline through Month 12 | |
Secondary | Percent of Participants Experiencing BMD Gains From Baseline of > 0%, > 3%, and > 6% at the Lumbar Spine, Femoral Neck, and Total Hip | Lumbar spine, femoral neck, and total hip BMD were assessed by DXA scans evaluated by a central imaging laboratory. | Month 12 | |
Secondary | Percent Change From Baseline in Total Hip Volumetric BMD as Measured by Quantitative Computed Tomography (QCT) at Month 12 | QCT scans were evaluated by a central imaging laboratory. | Baseline, Month 12 | |
Secondary | Percent Change From Baseline in Femoral Neck Volumetric BMD as Measured by QCT at Month 12 | QCT scans were evaluated by a central imaging laboratory. | Baseline, Month 12 |
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