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

NCT ID: NCT00859027

Last Updated: 2018-05-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo controlled trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Risedronate

35 mg by mouth every week as directed

Group Type EXPERIMENTAL

risedronate

Intervention Type DRUG

35 mg/week by mouth

risedronate placebo tablet

Calcium and vitamin D

Group Type PLACEBO_COMPARATOR

Placebo risedronate oral tablet

Intervention Type DRUG

One tablet by mouth every week as directed

Interventions

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risedronate

35 mg/week by mouth

Intervention Type DRUG

Placebo risedronate oral tablet

One tablet by mouth every week as directed

Intervention Type DRUG

Other Intervention Names

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Actonel

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Proctor and Gamble/Aventis

UNKNOWN

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Pamela Taxel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela Taxel, MD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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GCRC # 413

Identifier Type: -

Identifier Source: secondary_id

None given

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

None given

Identifier Type: OTHER

Identifier Source: secondary_id

02-062

Identifier Type: -

Identifier Source: org_study_id

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