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

NCT00859027 | Completed Phase 4 Results

• 3 other identifiers: 02-062GCRC # 413None given
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Non-metastatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percent Change of Bone Turnover Markers

  Baseline and 6 months

Study Arms (2)

Risedronate

EXPERIMENTAL

35 mg by mouth every week as directed

Drug: risedronate

risedronate placebo tablet

PLACEBO COMPARATOR

Calcium and vitamin D

Drug: Placebo risedronate oral tablet

Interventions

risedronate DRUG

35 mg/week by mouth

Also known as: Actonel

Risedronate

Placebo risedronate oral tablet DRUG

One tablet by mouth every week as directed

risedronate placebo tablet

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-metastatic prostate cancer
• Men to receive Gonadotropin-releasing Hormone-agonist therapy

You may not qualify if:

• Other cancers except skin cancer
• Evidence of metabolic bone disease
• Prior use of bisphosphonates

Sponsors & Collaborators

• UConn Health: lead
• Proctor and Gamble/Aventis: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Small number but otherwise no limitations.

Results Point of Contact

• Title: Pamela Taxel MD
• Organization: University of Connecticut Health Center

taxel@nso.uchc.edu

860-679-4743

Study Officials

• Pamela Taxel, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, placebo controlled trial.

Study Record Dates

• First Submitted: March 7, 2009
• First Posted: March 10, 2009
• Study Start: January 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: February 1, 2009
• Last Updated: May 1, 2018
• Results First Posted: August 1, 2013

Record last verified: 2018-04

Locations

US (1)