Conditions: Postmenopausal Osteoporosis
Keywords: BA058 Abaloparatide-SC abaloparatide ACTIVExtend osteoporosis fracture bone loss
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1139
Healthy volunteers: no

Brief summary:
The purpose of this study is to provide 24 months of standard of care data on participants previously enrolled in Study BA058-05-003 (NCT02653417).

Detailed description:
To assess the long-term effect of the anabolic drug, abaloparatide-subcutaneous (SC) versus placebo in the prevention of bone fracture after cessation of treatment. Participants who completed the 18-month Double-Blind BA058-05-003 (ACTIVE) study (NCT02653417), after receiving abaloparatide-SC or placebo, were enrolled in this extension study to receive 70 mg of alendronate (bisphosphonate) weekly for an additional 24 months. Complete details for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417.

Arms:
arm 1: Participants received 70 milligrams (mg) of alendronate orally once per week beginning on Day 2 for up to 24 months after participating in Study BA058-05-003 during which participants received abaloparatide 80 micrograms (mcg) SC or abaloparatide-matching placebo daily for 18 months.

Interventions: intervention 1: Alendronate
Intervention descriptions: intervention 1: Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.

Protocol document: