At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women
In Brief
A Phase 3 clinical trial evaluating Calcium Carbonate, Vitamin D3, and 2 other interventions for Osteopenia. Completed, enrolled 276 participants across 1 site.
Detailed Summary
The purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication "risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading exercises. Our central hypothesis is that improvements in bone health will be greater in women randomized to bone-loading exercises with calcium and vitamin D compared to women who take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.
Study Details
Timeline
Interventions
Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.