Last updated: 11/07/2018 05:14:06
CR9112792, a follow-up of Study CR9108963
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Study CR9112792, a study to assess bone mineral density changes in post-menopausal osteoporotic women following discontinuation of ronacaleret or placebo treatment in study CR9108963
Trial description: 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 cessation of ronacaleret therapy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4)
Timeframe: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit
Secondary outcomes:
Percent change in BMD, as measured by DXA, at the total hip, trochanter and femoral neck
Timeframe: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) and total hip, trochanter and femoral neck
Timeframe: 16 to 25 months from the screening CR9108963 DXA to the CR9112792 study visit
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) and total hip, trochanter and femoral neck
Timeframe: 12 to 18 months from the month 6 CR9108963 DXA to the CR9112792 study visit
Interventions:
Procedure/surgery: DXA
Enrollment:
171
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Fitzpatrick LA, Wooddell M, Dabrowski CE, Cicconetti G, Gordon DN.Bone mineral density changes following discontinuation of ronacaleret treatment: off-treatment extension of a randomized, dose-finding Phase II trial.Bone.2014;67:104-8doi: http://dx.doi.org/10.1016/j.bone.2014.04.024
Medical condition
Osteoporosis
Product
ronacaleret
Collaborators
Not applicable
Study date(s)
March 2009 to June 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
Not applicable+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2009-30-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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