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

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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