Prostate Cancer
Conditions
Keywords
Non-metastatic
Brief summary
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.
Detailed 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.
Interventions
DRUGrisedronate
35 mg/week by mouth
DRUGPlacebo risedronate oral tablet
One tablet by mouth every week as directed
Sponsors
Proctor and Gamble/Aventis
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, placebo controlled trial.
Eligibility
Sex/Gender
MALE
Age
55 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density | baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change of Bone Turnover Markers | Baseline and 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects recruited from medical clinics/ urology clinics.
Participants by arm
| Arm | Count |
|---|---|
| Risedronate Plus Calcium and Vit D | 25 |
| Calcium and Vitamin D | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Calcium and Vitamin D | Risedronate Plus Calcium and Vit D | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 17 Participants | 35 Participants |
| Age, Continuous | 72 years STANDARD_DEVIATION 7 | 70 years STANDARD_DEVIATION 9 | 71 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Percent Change in Bone Mineral Density | Femoral Neck | 0.1 Percent Change | Standard Error 0.2 |
| Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Percent Change in Bone Mineral Density | Total Hip | 0.2 Percent Change | Standard Error 0.3 |
| Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Percent Change in Bone Mineral Density | Lumbar Spine | 1.7 Percent Change | Standard Error 0.8 |
| Calcium and Vitamin D Daily (Placebo Group) | Percent Change in Bone Mineral Density | Femoral Neck | -2 Percent Change | Standard Error 0.5 |
| Calcium and Vitamin D Daily (Placebo Group) | Percent Change in Bone Mineral Density | Total Hip | -2.2 Percent Change | Standard Error 0.4 |
| Calcium and Vitamin D Daily (Placebo Group) | Percent Change in Bone Mineral Density | Lumbar Spine | -1.3 Percent Change | Standard Error 1 |
Comparison: Percent change in femoral neck BMD from baselinep-value: 0.004One way ANOVA
Comparison: Percent change in total hip BMD from baselinep-value: 0.001One way ANOVA
Comparison: Percent change in lumbar spine BMD from baselinep-value: 0.04One way ANOVA
Comparison: Between group difference of percent change for the femoral neck BMDp-value: <0.01ANOVA
Comparison: Between group difference of percent change for total hip BMDp-value: <0.01ANOVA
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.
Time frame: Baseline and 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Percent Change of Bone Turnover Markers | CTX | -5 Percent Change | Standard Error 4 |
| Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Percent Change of Bone Turnover Markers | Vitamin D | NA Percent Change | — |
| Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Percent Change of Bone Turnover Markers | P1NP | -1 Percent Change | Standard Error 2 |
| Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Percent Change of Bone Turnover Markers | PTH | NA Percent Change | — |
| Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily | Percent Change of Bone Turnover Markers | NTX | -15 Percent Change | Standard Error 3 |
| Calcium and Vitamin D Daily (Placebo Group) | Percent Change of Bone Turnover Markers | PTH | NA Percent Change | — |
| Calcium and Vitamin D Daily (Placebo Group) | Percent Change of Bone Turnover Markers | NTX | 21 Percent Change | Standard Error 2 |
| Calcium and Vitamin D Daily (Placebo Group) | Percent Change of Bone Turnover Markers | CTX | 55 Percent Change | Standard Error 5 |
| Calcium and Vitamin D Daily (Placebo Group) | Percent Change of Bone Turnover Markers | P1NP | 41 Percent Change | Standard Error 4 |
| Calcium and Vitamin D Daily (Placebo Group) | Percent Change of Bone Turnover Markers | Vitamin D | NA Percent Change | — |
Comparison: Between group difference of percent change for NTXp-value: 0.015ANOVA
Comparison: Between group difference of percent change for CTXp-value: 0.01ANOVA