Trial Outcomes & Findings for Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index (NCT NCT02435147)

NCT ID: NCT02435147

Last Updated: 2018-10-29

Results Overview

Proportion of change in mean trabecular bone score at 36 months following denosumab initiation

• Recruitment status: COMPLETED
• Target enrollment: 86 participants
• Primary outcome timeframe: Baseline and 36 months
• Results posted on: 2018-10-29

Participant Flow

This is a single-site, non-randomized observational study of post-menopusal women between the ages of 40 and 90 years who completed a minimum of 36 months of denosumab therapy for the treatment of osteoporosis and had evaluable DXA scans. Women were recruited to participate from a single clinical practice site between March 2015 and March 2016.

Participant milestones

Measure	Denosumab This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
Overall Study STARTED	86
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Denosumab This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
Overall Study non-evaluable DXA scan	11

Baseline Characteristics

Longitudinal Effects of Denosumab on Trabecular Bone Score and Femur Strength Index

Baseline characteristics by cohort

Measure	Denosumab n=75 Participants This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
Age, Continuous	71.6 years STANDARD_DEVIATION 9.71 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants
Trabecular Bone Score	1.257 units on a scale STANDARD_DEVIATION 0.09 • n=5 Participants
Femur Strength Index	1.291 units on a scale STANDARD_DEVIATION 0.287 • n=5 Participants
Lumbar Spine Bone Mineral Density	0.931 g/cm^2 STANDARD_DEVIATION 0.132 • n=5 Participants
Femoral Neck Bone Mineral Density	0.717 g/cm^2 STANDARD_DEVIATION 0.070 • n=5 Participants
Total Femur Bone Mineral Density	0.746 g/cm^2 STANDARD_DEVIATION 0.079 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 36 months

Proportion of change in mean trabecular bone score at 36 months following denosumab initiation

Outcome measures

Measure	Denosumab n=75 Participants This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
Proportion of Change in Mean Trabecular Bone Score	.00238 Proportion of change Standard Deviation 0.0422

SECONDARY outcome

Timeframe: Baseline and 36 months

Proportion of change in mean Femur Strength Index Score at 36 months following denosumab initiation

Outcome measures

Measure	Denosumab n=75 Participants This is a single-site, open-label, non-randomized observational study of postmenopausal women with osteoporosis being actively treated with denosumab. All participants received denosumab as part of their standard of care osteoporosis therapy.
Proportion of Change in Mean Femur Strength Index Score	.0838 Proportion of change Standard Deviation .2208

Adverse Events

Denosumab

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

Amy Fehrer

HealthEast Care System

Phone: 651-232-5363

Email: afehrer@healtheast.org

Results disclosure agreements

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