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| ID | Type | Description | Link |
|---|---|---|---|
| GCRC # 413 | |||
| None given | Other Grant/Funding Number | Procotor and Gamble/Aventis | |
| None given | Other Identifier | Procotor and Gamble/Aventis |
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| Name | Class |
|---|---|
| Proctor and Gamble/Aventis | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risedronate | Experimental | 35 mg by mouth every week as directed |
|
| risedronate placebo tablet | Placebo Comparator | Calcium and vitamin D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risedronate | Drug | 35 mg/week by mouth |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of Bone Turnover Markers | Bone turnover markers including N-telopeptide (NTX), serum C-telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Taxel, MD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
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Subjects recruited from medical clinics/ urology clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily | Pts receiving LHRH-agonists for prostate cancer received active risedronate. They also received daily calcium + Vit D |
| FG001 | Calcium and Vitamin D Daily (Placebo Group) | Pts received placebo risedronate + calcium and Vit D. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Risedronate Plus Calcium and Vit D | |
| BG001 | Calcium and Vitamin D | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Percent Change | baseline and 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium and Vitamin D |
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Small number but otherwise no limitations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Taxel MD | University of Connecticut Health Center | 860-679-4743 | taxel@nso.uchc.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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Randomized, placebo controlled trial.
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| Placebo risedronate oral tablet | Drug | One tablet by mouth every week as directed |
|
| Baseline and 6 months |
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Percent Change of Bone Turnover Markers | Bone turnover markers including N-telopeptide (NTX), serum C-telopeptide (CTX) and procollagen peptide (P1NP), and 25-OH vitamin D and intact parathyroid hormone (PTH) were measured at baseline and at 6 months. Reported means have been estimated from the results publication as the underlying data are no longer available. Data for Vitamin D and PTH were not included in the publication. | Posted | Mean | Standard Error | Percent Change | Baseline and 6 months |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Risedronate | Particiapnts given 35 mg by mouth every week | 0 | 25 | 0 | 25 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| P1NP |
|
| Vitamin D |
|
| PTH |
|
| 0.01 |
| Other |