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

UConn Health

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: risedronate; Drug: Placebo risedronate oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT00859027

02-062

None given (Other Grant/Funding Number)

GCRC # 413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Risedronate

Experimental group

Description:

35 mg by mouth every week as directed

Treatment:

Drug: risedronate

risedronate placebo tablet

Placebo Comparator group

Description:

Calcium and vitamin D

Treatment:

Drug: Placebo risedronate oral tablet