Trial Outcomes & Findings for Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer (NCT NCT00859027)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2018-05-01

Participant Flow

Subjects recruited from medical clinics/ urology clinics.

Participant milestones

Participant milestones
Measure	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	Calcium and Vitamin D Daily (Placebo Group) Pts received placebo risedronate + calcium and Vit D.
Overall Study STARTED	25	25
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risedronate Plus Calcium and Vit D n=25 Participants	Calcium and Vitamin D n=25 Participants	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	70 years STANDARD_DEVIATION 9 • n=5 Participants	72 years STANDARD_DEVIATION 7 • n=7 Participants	71 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily n=20 Participants	Calcium and Vitamin D Daily (Placebo Group) n=20 Participants
Percent Change in Bone Mineral Density Femoral Neck	0.1 Percent Change Standard Error 0.2	-2 Percent Change Standard Error 0.5
Percent Change in Bone Mineral Density Total Hip	0.2 Percent Change Standard Error 0.3	-2.2 Percent Change Standard Error 0.4
Percent Change in Bone Mineral Density Lumbar Spine	1.7 Percent Change Standard Error 0.8	-1.3 Percent Change Standard Error 1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily n=20 Participants	Calcium and Vitamin D Daily (Placebo Group) n=20 Participants
Percent Change of Bone Turnover Markers NTX	-15 Percent Change Standard Error 3	21 Percent Change Standard Error 2
Percent Change of Bone Turnover Markers CTX	-5 Percent Change Standard Error 4	55 Percent Change Standard Error 5
Percent Change of Bone Turnover Markers P1NP	-1 Percent Change Standard Error 2	41 Percent Change Standard Error 4
Percent Change of Bone Turnover Markers Vitamin D	NA Percent Change Standard Error NA Underlying data not available	NA Percent Change Standard Error NA Underlying data not available
Percent Change of Bone Turnover Markers PTH	NA Percent Change Standard Error NA Underlying data not available	NA Percent Change Standard Error NA Underlying data not available

Adverse Events

Calcium and Vitamin D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Risedronate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela Taxel MD

University of Connecticut Health Center

Phone: 860-679-4743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place