Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

Shire

Status and phase: Completed; Phase 3

Conditions: Hypoparathyroidism

Treatments: Drug: NPSP558

Study type: Interventional

Funder types: Industry

Identifiers

NCT01268098

PAR-C10-007

Details and patient eligibility

About

Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.

Full description

Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.

Enrollment: 42 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

1. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
2. With regard to female patients: women who are postmenopausal or willing to use two medically acceptable methods of contraception for the duration of the study with pregnancy testing conducted at every scheduled office visit
3. Total serum calcium ≤ ULN based on local laboratory results prior to randomization
4. Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization

Main Exclusion Criteria:

1. Any disease or condition that, in the opinion of the investigator, has a high probability of precluding the patient from completing the study or being able to appropriately comply with study requirements
2. Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
3. Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
4. Pregnant or lactating women
5. Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
6. Use of any experimental drug other than NPSP558 within 3 months of baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

25 µg dose

Experimental group

Description:

25 µg

Treatment:

Drug: NPSP558

50 µg dose

Experimental group

Description:

50 µg

Treatment:

Drug: NPSP558