Trial Outcomes & Findings for Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta (NCT NCT00131469)

NCT ID: NCT00131469

Last Updated: 2019-04-24

Results Overview

bone density by dual energy xray absorptiometry

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 79 participants
• Primary outcome timeframe: baseline and 18 months
• Results posted on: 2019-04-24

Participant Flow

One participant was formally enrolled but then dropped out before the first study treatment was administered.

Participant milestones

Measure	Teriparatide (FORTEO) Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily	Placebo Daily SQ placebo for 18 months Placebos
Overall Study STARTED	38	40
Overall Study COMPLETED	29	27
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Measure	Teriparatide (FORTEO) Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily	Placebo Daily SQ placebo for 18 months Placebos
Overall Study Withdrawal by Subject	3	4
Overall Study Protocol Violation	3	1
Overall Study Death	0	1
Overall Study Lost to Follow-up	0	1
Overall Study scan not analyzable	3	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Teriparatide (FORTEO) n=38 Participants Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily	Placebo n=40 Participants Daily SQ placebo for 18 months Placebos	Total n=78 Participants Total of all reporting groups
Age, Continuous	40.8 years STANDARD_DEVIATION 12.9 • n=38 Participants	41.2 years STANDARD_DEVIATION 10.1 • n=40 Participants	41 years STANDARD_DEVIATION 11.5 • n=78 Participants
Sex: Female, Male Female	22 Participants n=38 Participants	24 Participants n=40 Participants	46 Participants n=78 Participants
Sex: Female, Male Male	16 Participants n=38 Participants	16 Participants n=40 Participants	32 Participants n=78 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: baseline and 18 months

bone density by dual energy xray absorptiometry

Outcome measures

Measure	Teriparatide (FORTEO) n=29 Participants Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily	Placebo n=27 Participants Daily SQ placebo for 18 months Placebos
Spine Bone Mineral Density (BMD)	6.1 percentage of change in g/cm2 Standard Error 1.5	2.8 percentage of change in g/cm2 Standard Error 1.3

SECONDARY outcome

Timeframe: baseline and 18 months

bone density by dual energy xray absorptiometry

Outcome measures

Measure	Teriparatide (FORTEO) n=22 Participants Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months Teriparatide (FORTEO): Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily	Placebo n=26 Participants Daily SQ placebo for 18 months Placebos
Total Hip BMD	2.6 percentage of change in g/cm2 Standard Error 2	-2.4 percentage of change in g/cm2 Standard Error 1.8

Adverse Events

Teriparatide (FORTEO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Orwoll

OHSU

Phone: 15034940225

Email: orwoll@ohsu.edu

Results disclosure agreements

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