Status:
COMPLETED
CR9112792, a Follow-up of Study CR9108963
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoporosis
Eligibility:
FEMALE
Brief Summary
The purpose of this study is to determine whether bone mineral density has increased in a subgroup of postmenopausal osteoporotic women from study CR9108963, between 6 and 12 months following cessatio...
Detailed Description
CR9112792 is a follow-up study of CR9108963, the 12 month dose ranging study of ronacaleret (SB-751689), a calcium sensing receptor antagonist, in postmenopausal women with osteoporosis. CR9108963 eva...
Eligibility Criteria
Inclusion
- Informed consent: Subject is willing and able to provide written informed consent.
- Subjects: Subjects must have completed through the Month 12 visit of study CR9108963, or have had an early withdrawal visit on or after their Month 10 visit.
- DXA: Subjects must have either a final evaluable spine or hip DXA scan in CR9108963 as confirmed by Synarc, taken within 4 weeks of the last dose of study medication.
- Study medication: Subjects must have been on placebo or ronacaleret 200mg, 300mg or 400mg for ≥299 days in study CR9108963.
Exclusion
- Any treatment with a PTH-based therapy or strontium ranelate after discontinuation of treatment in study CR9108963.
- Chronic systemic corticosteroid \[e.g., glucocorticoid, mineralocorticoid\] treatment of more than 2 intra-articular injections within the past year or use of oral, parenteral, or long-term, high-dose inhaled corticosteroids. Treatment with any topical corticosteroid will not exclude the subject from participating.
- Treatment with any topical corticosteroid will not exclude the subject from participation.
- Treatment with fluoride (dose greater than 10mg/day) for osteoporosis after discontinuation of treatment in study CR9108963.
- Administration of any investigational drug after discontinuation of treatment in study CR9108963.
- Subject who, in the opinion of the investigator, is unfit for this study or unable to comply with the requirements of the protocol.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00891553
Start Date
March 1 2009
End Date
June 1 2009
Last Update
February 25 2013
Active Locations (3)
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1
GSK Investigational Site
Ballerup Municipality, Denmark, 2750
2
GSK Investigational Site
Bergen, Norway, 5094
3
GSK Investigational Site
Hamar, Norway, 2317