Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Age Related Osteoporosis
- Osteoporosis
- Osteoporosis Localized to Spine
- Osteoporosis of Vertebrae
- Osteoporosis Senile
- Osteoporosis, Age Related
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized patients will received a 2:1 ratio of abaloparatide:placebo injections.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Treatment will be blinded to participants, investigators, outcome Assessor and care provider throughout the study except in a medical emergency where the identity of study medication is necessary to appropriately treat the patient.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 85 years
- Gender
- Only males
Description
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide-SC 80 mcg per day compared to placebo as assessed by change in bone mineral density over 12 months.
The primary objective of this prospective controlled study is to evaluate the efficacy and the safety of abaloparatide-SC 80 mcg per day compared to placebo as assessed by change in bone mineral density over 12 months.
Tracking Information
- NCT #
- NCT03512262
- Collaborators
- Not Provided
- Investigators
- Study Director: Sr. Director, Clinical Operations Radius Health, Inc.
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