A Phase 4 interventional study of risedronate and Placebo risedronate oral tablet in Prostate Cancer, sponsored by UConn Health. Completed at 1 site in United States. Open to male participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by UConn Health · Phase 4, Interventional, and Treatment
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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Exclusion Criteria:
35 mg by mouth every week as directed
Drug: risedronate
Calcium and vitamin D
Drug: Placebo risedronate oral tablet
35 mg/week by mouth
Also known as: Actonel
One tablet by mouth every week as directed
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.
Time frame: baseline and 6 months
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.
Time frame: Baseline and 6 months
Subjects recruited from medical clinics/ urology clinics.
| Milestone | Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily | Calcium and Vitamin D Daily (Placebo Group) |
|---|---|---|
| Started | 25 | 25 |
| Completed | 20 | 20 |
| Not completed | 5 | 5 |
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.
| Percent Change | Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Calcium and Vitamin D Daily (Placebo Group) |
|---|---|---|
| Femoral Neck | 0.1 ± 0.2 | -2 ± 0.5 |
| Total Hip | 0.2 ± 0.3 | -2.2 ± 0.4 |
| Lumbar Spine | 1.7 ± 0.8 | -1.3 ± 1 |
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.
| Percent Change | Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Calcium and Vitamin D Daily (Placebo Group) |
|---|---|---|
| NTX | -15 ± 3 | 21 ± 2 |
| CTX | -5 ± 4 | 55 ± 5 |
| P1NP | -1 ± 2 | 41 ± 4 |
| Vitamin D | NA ± NA | NA ± NA |
| PTH | NA ± NA | NA ± NA |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Calcium and Vitamin D | — | 0/25 (0%) | 0/25 (0%) |
| Risedronate | — | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Risedronate Plus Calcium and Vit D | Calcium and Vitamin D | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 18 | 35 |
| >=65 years | 8 | 7 | 15 |
| Age, Continuous(years) | Risedronate Plus Calcium and Vit D | Calcium and Vitamin D | Total |
|---|---|---|---|
| Mean | 70 ± 9 | 72 ± 7 | 71 ± 8 |
| Sex: Female, Male(Participants) | Risedronate Plus Calcium and Vit D | Calcium and Vitamin D | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 25 | 25 | 50 |
| Region of Enrollment(participants) | Risedronate Plus Calcium and Vit D | Calcium and Vitamin D | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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