Trial Outcomes & Findings for Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP (NCT NCT02049866)

NCT ID: NCT02049866

Last Updated: 2022-12-12

Results Overview

Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 33 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2022-12-12

Participant Flow

Participant milestones

Measure	Denosumab Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Overall Study STARTED	33
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Denosumab Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP

Baseline characteristics by cohort

Measure	Denosumab n=33 Participants Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	33 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	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: 33 participants completed baseline but 1 participant withdrew from the study before the 12 month visit.

Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).

Outcome measures

Measure	Denosumab n=32 Participants Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Percent Change in Lumbar Spine Areal BMD by DXA	5.2 percentage of change Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline and 24 months

Bone mineral density (BMD) will be measured with dual-energy X-ray absorptiometry (DXA).

Outcome measures

Measure	Denosumab n=29 Participants Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Percent Change in Lumbar Spine Areal BMD by DXA at 24 Months	6.9 percentage of change Standard Deviation 2.6

Adverse Events

Denosumab

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Denosumab n=33 participants at risk Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months. Denosumab: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Musculoskeletal and connective tissue disorders Fracture	9.1% 3/33 • Number of events 3 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Surgical and medical procedures Redness	6.1% 2/33 • Number of events 2 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Surgical and medical procedures Pain	27.3% 9/33 • Number of events 9 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Infections and infestations Urinary tract infection	36.4% 12/33 • Number of events 12 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Infections and infestations Ear infection	9.1% 3/33 • Number of events 3 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Skin and subcutaneous tissue disorders Eczema	6.1% 2/33 • Number of events 2 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Skin and subcutaneous tissue disorders Rash	6.1% 2/33 • Number of events 2 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Skin and subcutaneous tissue disorders Hair loss	9.1% 3/33 • Number of events 3 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Musculoskeletal and connective tissue disorders Muscle cramps	12.1% 4/33 • Number of events 4 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Nervous system disorders Numbness and/or tingling	18.2% 6/33 • Number of events 6 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Gastrointestinal disorders Nausea and vomiting	6.1% 2/33 • Number of events 2 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Musculoskeletal and connective tissue disorders Pain in thighs, hips, or groin	33.3% 11/33 • Number of events 11 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Respiratory, thoracic and mediastinal disorders Cold	36.4% 12/33 • Number of events 12 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
Musculoskeletal and connective tissue disorders Joint pain	6.1% 2/33 • Number of events 2 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).
General disorders Low Energy	12.1% 4/33 • Number of events 4 • Adverse event data was collected for 1 year (from baseline to 12 month study participation).

Additional Information

Mariana Bucovsky

Columbia University

Phone: 212-305-7225

Email: mb3523@cumc.columbia.edu

Results disclosure agreements

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