Trial Outcomes & Findings for Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption (NCT NCT01750086)

Results Overview

The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-03-27

Participant milestones
Measure	Denosumab 60mg Subcutaneous Injection Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection	Alendronate 70mg Weekly x 8 Weeks Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection
Overall Study STARTED	13	14
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	1	1

Withdrawal data not reported

Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Baseline characteristics by cohort
Measure	Denosumab 60mg Subcutaneous Injection n=12 Participants Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection	Alendronate 70mg Weekly x 8 Weeks n=13 Participants Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection	Total n=25 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 7 • n=5 Participants	66 years STANDARD_DEVIATION 8 • n=7 Participants	66 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants

Timeframe: 8 weeks

The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.

Outcome measures
Measure	Denosumab 60mg Subcutaneous Injection n=12 Participants Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection	Alendronate 70mg Weekly x 8 Weeks n=13 Participants Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection
Bone Turnover Marker (Blood Sample)	-7 percentage of change in CTX Standard Deviation 11	43 percentage of change in CTX Standard Deviation 29

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Denosumab 60mg Subcutaneous Injection n=12 participants at risk Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection	Alendronate 70mg Weekly x 8 Weeks n=13 participants at risk Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection
Endocrine disorders Lightheadedness	8.3% 1/12	0.00% 0/13
Endocrine disorders Syncope	0.00% 0/12	7.7% 1/13

Adverse event data not reported

Massachusetts General Hospital

Phone: 617-726-6723