CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 26 enrolled
Drug / intervention
Teriparatide +1 moredrug
Likely dose
Teriparatide 20 mcgfrom record
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Search/NCT01166958
NCT01166958Phase 4Completed

Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?

University of Wisconsin, Madison·interventional·Posted Jul 21, 2010·Updated Sep 22, 2014

In Brief

A Phase 4 clinical trial evaluating Teriparatide and Raloxifene for Osteoporosis. Completed, enrolled 26 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 21, 2010
Enrollment StartSep 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.9 years ago

Interventions

Teriparatidedrug

Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.

Raloxifenedrug

Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.