Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Placebo risedronate oral tablet; Drug: risedronate

• Registration Number: NCT00859027
• Lead Sponsor: UConn Health

Brief 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.

Detailed Description

A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was measured every 6 months. In addition, bone turnover markers including N-telopeptide, serum C-telopeptide and procollagen peptide, and 25-OH vitamin D and intact parathyroid hormone were measured at baseline and at 6 months.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2008-03
• Study Completion: 2009-02
• Study First Submitted: 2009-03-07
• Study First Submitted QC: 2009-03-07
• Study First Posted: 2009-03-10
• Results First Submitted: 2012-08-22
• Results First Submitted QC: 2013-06-28
• Results First Posted: 2013-08-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
risedronate placebo tablet	Placebo risedronate oral tablet	Calcium and vitamin D
Risedronate	risedronate	35 mg by mouth every week as directed

Primary Outcome Measures

Name	Time	Method
Percent Change in Bone Mineral Density	baseline and 6 months	BMD was measured by dual-energy X-ray absorptiometry (Lunar DXA-IQ, Madison, WI, USA). The BMD of the femoral neck, total hip, and lumbar spine (L1-L4) was measured. Underlying data are no longer available; reported means have been estimated from the results publication.

Secondary Outcome Measures

Name	Time	Method
Percent Change of Bone Turnover Markers	Baseline and 6 months	Bone turnover markers including N-telopeptide (NTX), serum C-telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication.

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States