Trial Outcomes & Findings for HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism (NCT NCT01199614)

NCT ID: NCT01199614

Last Updated: 2024-07-05

Results Overview

Serum and urinary calcium levels maintained by change in requirements for calcium supplementation.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline, up to 4 years
• Results posted on: 2024-07-05

Participant Flow

Participant milestones

Measure	Open-label PTH(1-84) open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day
Overall Study STARTED	62
Overall Study Completed	27
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HEXT (Hypo EXTended): Effect of PTH on Skeleton in Hypoparathyroidism

Baseline characteristics by cohort

Measure	Open-label PTH(1-84) n=62 Participants open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day
Age, Customized 18-21 years	0 Participants n=5 Participants
Age, Customized 22-29 years	5 Participants n=5 Participants
Age, Customized 30-39 years	7 Participants n=5 Participants
Age, Customized 40-49 years	22 Participants n=5 Participants
Age, Customized 50-59 years	13 Participants n=5 Participants
Age, Customized 60-69 years	13 Participants n=5 Participants
Age, Customized 70-79 years	2 Participants n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, up to 4 years

Population: Analyzed data from this cohort included 27 evaluable subjects treated with open-label PTH(1-84) for 4 years.

Serum and urinary calcium levels maintained by change in requirements for calcium supplementation.

Outcome measures

Measure	Open-label PTH(1-84) n=27 Participants open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day
Change in Dose of Calcium Supplementation	37 percent change in dose Standard Deviation 43

SECONDARY outcome

Timeframe: Baseline, up to 4 years

Population: Analyzed data from this cohort included 27 evaluable subjects treated with open-label PTH(1-84) for 4 years.

Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DXA)

Outcome measures

Measure	Open-label PTH(1-84) n=27 Participants open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day
Percent Change in BMD by DXA	5.5 percent change in BMD Standard Deviation 9

Adverse Events

Open-label PTH(1-84)

Serious events: 25 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Open-label PTH(1-84) n=62 participants at risk open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day
Endocrine disorders Hypercalcemia	1.6% 1/62 • Number of events 1 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Endocrine disorders Hypocalcemia	21.0% 13/62 • Number of events 13 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Infections and infestations Pneumonia	3.2% 2/62 • Number of events 2 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Surgical and medical procedures Surgery elective	4.8% 3/62 • Number of events 3 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Endocrine disorders Swelling of face, tongue	4.8% 3/62 • Number of events 3 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Gastrointestinal disorders Gastroenteretis	1.6% 1/62 • Number of events 1 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Reproductive system and breast disorders Infection in uterus	3.2% 2/62 • Number of events 2 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term

Other adverse events

Measure	Open-label PTH(1-84) n=62 participants at risk open-label PTH(1-84) / variable dosing: 25mcg every other day, 25mcg every day, 50mcg every day, 75mcg every day, 100mcg every day
Musculoskeletal and connective tissue disorders Muscular/skeletal event	25.8% 16/62 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Vascular disorders Circulatory event	6.5% 4/62 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Gastrointestinal disorders Digestive event	8.1% 5/62 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Endocrine disorders Endocrine/Nutritional event	14.5% 9/62 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
General disorders Infection	12.9% 8/62 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Nervous system disorders Nervous system event	8.1% 5/62 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
Renal and urinary disorders Urinary event	6.5% 4/62 • Up to 4 years Adverse Events were monitored/assessed without regard to the specific Adverse Event Term

Additional Information

John P. Bilezikian, MD

Columbia University

Phone: 212-305-6257

Email: jpb2@cumc.columbia.edu

Results disclosure agreements

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