Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis
NCT01535027 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2013-01-03
Summary
Increased bone formation in the absence of accelerated resorption is resulting in a marked anabolic response to teriparatide (TPTD) during the early phase after treatment initiation. Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing anabolic effects are accompanied by significantly increased bone resorption as well. Antiresorptives influence the balance of bone formation and resorption. Therefore the investigators aim is to investigate the effects of the addition of antiresorptives to the second half of TPTD cycle when resorption is already also markedly elevated.
Conditions
Interventions
- DRUG
-
teriparatide
teriparatide 20 ug/day, sc.
- DRUG
-
teriparatide and raloxifene
teriparatide 20 ug/day sc. raloxifene 60mg oral daily
- DRUG
-
teriparatide and alendronate
teriparatide 20 ug/day sc. alendronate 70mg oral weekly
Sponsors & Collaborators
-
Medical University of Vienna
lead OTHER
Principal Investigators
-
Christian Muschitz, M.D. · Medical University of Vienna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Max Age
- 88 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- Austria
Study Locations
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