Clinical trial · Interventional
Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients With Prostate Cancer
Osteoporosis Prevention in Prostate Cancer Patients Receiving Androgen Ablation Therapy: A Phase III Randomized, Placebo-Controlled, Double-Blind Study
NCT00043069CI-TRIAL-00025042completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Preventing bone loss in patients who are undergoing androgen ablation for prostate cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without estrogen and/or risedronate in preventing osteoporosis. PURPOSE: Randomized phase III trial to compare the effectiveness of two forms of calcium with or without estrogen and/or risedronate in preventing osteoporosis in patients with prostate cancer who are receiving androgen ablation therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteoporosis | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium carbonate | Dietary Supplement | — | UNRESOLVED |
| cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| Estrogen Antagonists | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| risedronate sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm I: calcium + cholecalciferol + placebo + estrogen
- description
- Patients receive oral calcium, oral cholecalciferol, oral risedronate placebo, and oral estrogen placebo daily. Treatment in all arms continues for 2 years. Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years. Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
- interventionNames
- Dietary Supplement: calcium carbonate
- Dietary Supplement: cholecalciferol
- Drug: Estrogen Antagonists
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II: calcium + cholecalciferol + risedronate + estrogen
- description
- Patients receive oral calcium, oral cholecalciferol, oral risedronate, and oral estrogen placebo daily. Treatment in all arms continues for 2 years. Quality of life is assessed at baseline, monthly for 6 months, and then at 1 and 2 years. Bone mineral density is assessed at baseline, 6 months, and 1 and 2 years.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * History of prostate cancer * No evidence of metastatic bony disease\* NOTE: \*Elevated prostate-specific antigen (PSA) allowed * Meets one of the following criteria: * Currently on treatment with androgen-ablation therapy in the adjuvant setting * Rising PSA without other evidence of recurrent disease with planned treatment for at least 6 months * No known osteoporosis or prior osteoporotic fracture * Osteoporosis defined as bone density at the hip or spine of more than 2.5 standard deviations below the mean for young men PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * SGOT or SGPT no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase normal OR no greater than 1.5 times ULN with a normal bone scan Renal * Creatinine no greater than 1.5 times ULN * No prior symptomatic hypercalcemia or hypocalcemia Cardiovascular * No active heart disease * No congestive heart failure under active treatment * No myocardial infarction within the past 5 years * No coronary artery disease (CAD) with recent myocardial infarction * Patients with a remote history of CAD who are only on medical treatment (e.g., antilipid agents) are allowed * No prior thrombosis (deep vein thrombosis, stroke, or pulmonary embolism) or other known hypercoagulable state other than cancer Other * Fertile patients must use effective contraception * Triglycerides no greater than 250 mg/dL (treatment allowed) * Able to complete questionnaire(s) by self or with assistance * Able to swallow pills * No prior hyperlipidemia (e.g., prior familial hyperlipidemia or fasting triglyceride greater than 250 mg/dL within the past 6 months) * No sarcoidosis * No parathyroid dysfunction * No intolerance to bisphosphonates PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent systemic steroids Radiotherapy * No concurrent radiotherapy Surgery * More than 3 months since prior and no concurrent dental extraction, root canal, or dental implantation Other * No prior bisphosphonates * More than 5 years since prior percutaneous transluminal coronary angioplasty
References
Publications (1)
- RESULTKearns AE, Northfelt DW, Dueck AC, Atherton PJ, Dakhil SR, Rowland KM Jr, Fuloria J, Flynn PJ, Dentchev T, Loprinzi CL. Osteoporosis prevention in prostate cancer patients receiving androgen ablation therapy: placebo-controlled double-blind study of estradiol and risedronate: N01C8. Support Care Cancer. 2010 Mar;18(3):321-8. doi: 10.1007/s00520-009-0655-x. Epub 2009 May 27. PMID 19468757