Trial Outcomes & Findings for The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa (NCT NCT00759772)

NCT ID: NCT00759772

Last Updated: 2017-05-11

Results Overview

Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2017-05-11

Participant Flow

Participant milestones

Measure	Teriparatide Teriparatide: Teriparatide 20 mcg sc daily for 6 months	Placebo Placebo: Placebo 20 mcg sc daily for 6 months
Overall Study STARTED	12	11
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Parathyroid Hormone (PTH) in Low Bone Mass in Anorexia Nervosa

Baseline characteristics by cohort

Measure	Teriparatide n=12 Participants Teriparatide: Teriparatide 20 mcg sc daily for 6 months	Placebo n=11 Participants Placebo: Placebo 20 mcg sc daily for 6 months	Total n=23 Participants Total of all reporting groups
Age, Continuous	47.6 years STANDARD_DEVIATION 9.6 • n=5 Participants	47.1 years STANDARD_DEVIATION 7.6 • n=7 Participants	47.3 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 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	11 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: All participants were included in analysis (intention to treat).

Percent increase or decrease in lumbar spine bone mineral density between baseline and 6 months (treatment period)

Outcome measures

Measure	Teriparatide n=12 Participants Teriparatide: Teriparatide 20 mcg sc daily for 6 months	Placebo n=11 Participants Placebo: Placebo 20 mcg sc daily for 6 months
Percent Change in Lumbar Spine Bone Mineral Density	5.6 percentage of change Standard Error 1.3	0.2 percentage of change Standard Error 0.7

Adverse Events

Teriparatide

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Teriparatide n=12 participants at risk Teriparatide: Teriparatide 20 mcg sc daily for 6 months	Placebo n=12 participants at risk；n=11 participants at risk Placebo: Placebo 20 mcg sc daily for 6 months
Psychiatric disorders Hospitalization or exacerbation	16.7% 2/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	27.3% 3/11 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.

Other adverse events

Measure	Teriparatide n=12 participants at risk Teriparatide: Teriparatide 20 mcg sc daily for 6 months	Placebo n=12 participants at risk；n=11 participants at risk Placebo: Placebo 20 mcg sc daily for 6 months
Nervous system disorders Lightheadedness	33.3% 4/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	50.0% 6/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.
Musculoskeletal and connective tissue disorders Muscle pain/spasm	25.0% 3/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	33.3% 4/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.
Gastrointestinal disorders Nausea	8.3% 1/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	41.7% 5/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.
Gastrointestinal disorders Vomiting	8.3% 1/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	25.0% 3/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.
Nervous system disorders Headache	50.0% 6/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	41.7% 5/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.
Skin and subcutaneous tissue disorders Injection site ecchymoses, bruising, erythema	66.7% 8/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	75.0% 9/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.
Endocrine disorders Elevated serum calcium	25.0% 3/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	0.00% 0/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.
Endocrine disorders Elevated 24hr urine calcium	25.0% 3/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.	8.3% 1/12 • 6 months Adverse events were monitored/assessed without regard to the specific Adverse Event Term. Adverse event descriptions are listed in the table.

Additional Information

Pouneh K. Fazeli, MD

Massachusetts General Hospital

Phone: 617-726-3870

Email: pkfazeli@partners.org

Results disclosure agreements

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