Trial Outcomes & Findings for Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women (NCT NCT00697463)

Results Overview

Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

22 participants

Primary outcome timeframe

Baseline, Month 18 or 24 reported

Results posted on

2018-07-26

Participant Flow

Premenopausal women, aged 20-48, with documented adult low trauma fractures or low aBMD by DXA; T score\<-2.5 or Z score\<-2.0 at the spine or hip and no history of adult low trauma fracture, were recruited at Columbia University Medical Center, NY and Creighton University, NE by advertisement, self- or physician referral.

No pre-assignment details to report

Participant milestones

Participant milestones
Measure	Women With Idiopathic Osteoporosis (IOP) Each subject will receive 20 micrograms of teriparatide subcutaneously daily. Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18- 24 months
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Women With Idiopathic Osteoporosis (IOP) Each subject will receive 20 micrograms of teriparatide subcutaneously daily. Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18- 24 months
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women With Idiopathic Osteoporosis (IOP) n=22 Participants Each subject will receive 20 micrograms of teriparatide subcutaneously daily. Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18-24 months
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.6 years STANDARD_DEVIATION 5.4 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 18 or 24 reported

Population: Of 22 women with IOP who enrolled, one withdrew for personal reasons, therefore the overall number of participants analyzed is 21. The percentage of BMD change is calculated for each participant between baseline and Month 24 or between baseline and Month 18, whichever is the longer reported timeframe as some are lost to follow up by Month 24.

Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.

Outcome measures

Outcome measures
Measure	Women With Idiopathic Osteoporosis (IOP) n=21 Participants Each subject will receive 20 micrograms of teriparatide subcutaneously daily. Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18-24 months
Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)	10.8 percentage of BMD change Standard Deviation 8.3

Adverse Events

Women With Idiopathic Osteoporosis (IOP)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Women With Idiopathic Osteoporosis (IOP) n=21 participants at risk Each subject will receive 20 micrograms of teriparatide subcutaneously daily. Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18-24 months
Blood and lymphatic system disorders Hypercalcemia	4.8% 1/21 • Number of events 1 • Adverse events were assessed through study completion. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same.
Renal and urinary disorders Hypercalciuria	28.6% 6/21 • Number of events 7 • Adverse events were assessed through study completion. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same.
Musculoskeletal and connective tissue disorders Distal radius fracture	4.8% 1/21 • Number of events 1 • Adverse events were assessed through study completion. The definition of adverse event and/or serious adverse event used to collect adverse event information is the same.

Additional Information

Elizabeth Shane, MD

Columbia University

Phone: 212-305-7225

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place