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Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?
Current osteoporosis therapies produce a prompt increase in bone mass, followed by only modest or no further subsequent gains. This limitation, known as the "remodeling transient," reflects the "coupling" of bone resorption with formation such that interventions impacting either of these processes lead to compensatory changes of the other. For example, medications which increase bone formation promptly also stimulate bone resorption. Thus, given the need to dramatically increase bone mass in patients with osteoporosis, it is necessary to "uncouple" formation and resorption. The investigators believe this to be possible using currently existing FDA-approved therapeutic agents, by using a novel, sequential approach. This pilot project will obtain preliminary data essential to support future work. In this study, the investigators will begin to explore the use of sequential anabolic treatment with teriparatide followed by antiresorptive therapy with raloxifene. The investigators propose that such sequential treatment will allow opening of the "anabolic window," the brief period of time following initiation of teriparatide therapy in which bone formation exceeds resorption.
Details
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 26 |
| Start date | 2010-09 |
| Completion | 2012-11 |
Conditions
- Osteoporosis
Interventions
- Teriparatide
- Raloxifene
Primary outcomes
- Serum Markers of Skeletal Turnover (Serum CTX) — These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.
Serum CTX was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points. - Serum Markers of Skeletal Turnover (Serum P1NP) — These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.
Serum P1NP was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.
Countries
United States