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

Prostate Cancer Clinical Trial

Official title:

The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859027
• Other study ID #: 02-062
• Secondary ID: GCRC # 413None g
• Status: Completed
• Phase: Phase 4
• Start date: January 2003
• Est. completion date: February 2009

Study information

• Verified date: April 2018
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• risedronate
35 mg/week by mouth
• Placebo risedronate oral tablet
One tablet by mouth every week as directed

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Proctor and Gamble/Aventis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Bone Mineral Density	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.	baseline and 6 months
Secondary	Percent Change of Bone Turnover Markers	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.	Baseline and 6 months