Phase 3
N=42
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
Hypoparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT01268098 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. — 21.1; 26.1 percentage of participants — p=>0.999
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NPSP558 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. |
21.1; 26.1 | >0.999 |
| SECONDARY The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. |
10.5; 26.1 | 0.258 |
Summary
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.
Eligibility Criteria
Main Inclusion Criteria:
- Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
- 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
- Total serum calcium ≤ ULN based on local laboratory results prior to randomization
- Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization
Main Exclusion Criteria:
- 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
- Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
- Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
- Pregnant or lactating women
- Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
- Use of any experimental drug other than NPSP558 within 3 months of baseline.
Data sourced from ClinicalTrials.gov (NCT01268098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.