Trial Outcomes & Findings for Weight Loss With Risedronate for Bone Health (NCT NCT03411902)

NCT ID: NCT03411902

Last Updated: 2021-02-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2021-02-09

Participant Flow

Participant milestones

Measure	Risedronate Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Overall Study STARTED	11	13
Overall Study COMPLETED	8	13
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Risedronate Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Overall Study Lost to Follow-up	3	0

Baseline Characteristics

Weight Loss With Risedronate for Bone Health

Baseline characteristics by cohort

Measure	Risedronate n=11 Participants Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 Participants Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Total n=24 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 7.7 • n=5 Participants	57.3 years STANDARD_DEVIATION 5.7 • n=7 Participants	55.7 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Risedronate n=11 Participants Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 Participants Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Number of Enrolled Participants That Completed All 24 Week Procedures	8 Participants	13 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: 3 subjects were lost to follow up in the risedronate arm

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition

Outcome measures

Measure	Risedronate n=8 Participants Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 Participants Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Fat Pounds	45.6 pounds Interval 41.8 to 49.4	40.6 pounds Interval 37.9 to 43.4

SECONDARY outcome

Timeframe: 24 weeks

Population: 3 subjects were lost to follow up in the risedronate arm

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition

Outcome measures

Measure	Risedronate n=8 Participants Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 Participants Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Lean Pounds	50.4 pounds Interval 49.1 to 51.8	50.7 pounds Interval 49.7 to 51.7

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Three subjects were lost to follow up in the risedronate arm.

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Total Hip Density measured in g/cm^2

Outcome measures

Measure	Risedronate n=8 Participants Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 Participants Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Total Change in Femoral Neck Hip Density	-0.028 g/cm^2 Interval -0.049 to -0.006	-0.047 g/cm^2 Interval -0.063 to -0.03

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Population: Three subjects were lost to follow up in the risedronate arm.

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure for Lumbar Spine Density measured in g/cm^2

Outcome measures

Measure	Risedronate n=8 Participants Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 Participants Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Total Change in Lumbar Spine Density	0.028 g/cm^2 Interval -0.006 to 0.063	-0.029 g/cm^2 Interval -0.054 to -0.004

SECONDARY outcome

Timeframe: 24 weeks

Population: Three subjects were lost to follow up in the risedronate arm.

Total change in ultradistal radius density measure in g/cm^2

Outcome measures

Measure	Risedronate n=8 Participants Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 Participants Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density Radius UD BMD (g/cm^2)	0.000 g/cm^2 Interval -0.017 to 0.017	-0.013 g/cm^2 Interval -0.026 to 0.001
Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density Radius 33 BMD (g/cm^2)	-0.002 g/cm^2 Interval -0.027 to 0.023	-0.016 g/cm^2 Interval -0.036 to 0.004

SECONDARY outcome

Timeframe: 24 weeks

Population: Three subjects were lost to follow up in the risedronate arm.

TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS >=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS <=1.200 defines degraded microarchitecture

Outcome measures

Measure	Risedronate n=8 Participants Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 Participants Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Trabecular Bone Score (TBS)	1.478 score on a scale Interval 1.413 to 1.543	1.485 score on a scale Interval 1.436 to 1.533

Adverse Events

Risedronate

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Risedronate n=11 participants at risk Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 participants at risk Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Endocrine disorders thyroid cancer	9.1% 1/11 • Number of events 1 • baseline through 12 months	0.00% 0/13 • baseline through 12 months
Skin and subcutaneous tissue disorders melanoma	9.1% 1/11 • Number of events 1 • baseline through 12 months	0.00% 0/13 • baseline through 12 months

Other adverse events

Measure	Risedronate n=11 participants at risk Experimental: Risedronate sodium,150 mg capsule once every 4 weeks for 24 weeks. Risedronate Sodium 150 MG: Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.	Placebo n=13 participants at risk Active comparator: Identical 150 mg placebo capsules once every 4 weeks for 24 weeks. Placebo: Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
Nervous system disorders headache	0.00% 0/11 • baseline through 12 months	7.7% 1/13 • Number of events 1 • baseline through 12 months
Skin and subcutaneous tissue disorders psoriasis	9.1% 1/11 • Number of events 1 • baseline through 12 months	0.00% 0/13 • baseline through 12 months
Gastrointestinal disorders nausea	9.1% 1/11 • Number of events 1 • baseline through 12 months	7.7% 1/13 • Number of events 1 • baseline through 12 months
Gastrointestinal disorders gastroesophageal reflux disease exacerbation	0.00% 0/11 • baseline through 12 months	7.7% 1/13 • Number of events 1 • baseline through 12 months
Musculoskeletal and connective tissue disorders broken ankle	9.1% 1/11 • Number of events 1 • baseline through 12 months	0.00% 0/13 • baseline through 12 months
Musculoskeletal and connective tissue disorders Broken humerus	9.1% 1/11 • Number of events 1 • baseline through 12 months	0.00% 0/13 • baseline through 12 months

Additional Information

Kristen Beavers

Wake Forest School of Medicine

Phone: 336-758-5855

Email: beaverkm@wfu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place