Conditions: Osteoporosis
Keywords: osteoporosis zoledronic acid forteo
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo, in postmenopausal women.

Detailed description:
This will be a single center open label proof of concept study, recruiting subjects previously treated with Forteo for at least 12 months.

A screening period of 3 to 6 weeks will precede the treatment period. At the baseline visit, patients whose eligibility is confirmed will be treated with ZA and followed for 12 months. Safety and efficacy will be assessed at regular intervals (day one, day 10, month 2, month 6, month 9 and month 12). Renal safety will be assessed prior to the i.v. dose of study medication, day 10 after the i.v. dose of study medication and at 12 months. Bone density at the lumbar spine (L1-4) and total hip will be performed at 6 months and at the end of the 12 month treatment period. Biomarker analyses for secondary endpoint will be performed for at day 10, month 2, month 6, month 9 and month 12.

Arms:
arm 1: 5 mg zoledronic acid in a single 15 minute IV

Interventions: intervention 1: zoledronic acid
Intervention descriptions: intervention 1: 5 mg zoledronic acid administered in a single 15 minute IV

Protocol document: