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Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis
- Source :
- Mayo Clinic Proceedings. 92:200-210
- Publication Year :
- 2017
- Publisher :
- Elsevier BV, 2017.
-
Abstract
- Objective To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis). Patients and Methods ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients. Results Of 1243 eligible ACTIVE patients, 1139 (92%) were enrolled in ACTIVExtend beginning November 20, 2012. These results are from a prespecified 6-month interim analysis (cutoff date, June 2, 2015); the study is ongoing. Findings indicated percentages of patients with new morphometric vertebral fractures: PBO/ALN, 4.4% vs ABL-SC/ALN, 0.55%; relative risk reduction, 87% (relative risk, 0.13; 95% CI, 0.04-0.41; P Conclusion Use of ABL-SC for 18 months followed by ALN for 6 months improved bone mineral density and reduced fracture risk throughout the skeleton and may be an effective treatment option for postmenopausal women with osteoporosis. Trial Registration clinicaltrials.gov Identifier: NCT01657162.
- Subjects :
- Medicine(all)
0301 basic medicine
Relative risk reduction
medicine.medical_specialty
Intention-to-treat analysis
Bone density
business.industry
Abaloparatide
Osteoporosis
030209 endocrinology & metabolism
General Medicine
medicine.disease
Interim analysis
Placebo
Surgery
03 medical and health sciences
030104 developmental biology
0302 clinical medicine
Teriparatide
Medicine
business
medicine.drug
Subjects
Details
- ISSN :
- 00256196
- Volume :
- 92
- Database :
- OpenAIRE
- Journal :
- Mayo Clinic Proceedings
- Accession number :
- edsair.doi.dedup.....f72a73e5bde2e07de473974b8a9f5ff3
- Full Text :
- https://doi.org/10.1016/j.mayocp.2016.10.009