Phase 4
Completed N=50
Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
Source: ClinicalTrials.gov NCT00859027 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Percent Change in Bone Mineral Density — 0.1; -2; 0.2; -2.2 Percent Change — p=0.004
Summary
Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Bone Mineral Density |
0.1; -2; 0.2; -2.2; 1.7; -1.3 | 0.004 sig |
| SECONDARY Percent Change of Bone Turnover Markers |
-15; 21; -5; 55; -1; 41 | 0.015 sig |
Eligibility Criteria
Inclusion Criteria
- Non-metastatic prostate cancer
- Men to receive Gonadotropin-releasing Hormone-agonist therapy
Exclusion Criteria
- Other cancers except skin cancer
- Evidence of metabolic bone disease
- Prior use of bisphosphonates
Data sourced from ClinicalTrials.gov (NCT00859027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.