CR9112792, a Follow-up of Study CR9108963

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Procedure: DXA

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 evaluated the effects of ronacaleret (100mg, 200mg, 300mg, 400mg) on bone mineral density (BMD), safety and tolerability in comparison with placebo and 2 active comparators, alendronate and teriparatide. CR9108963 was terminated earlier than planned due to an observed lack of efficacy in lumbar spine and hip BMD. In this study we will follow-up subjects between 6 and 12 months after they discontinued treatment with ronacaleret to evaluate the potential for mineralization of bone following cessation of ronacaleret therapy. Subjects at pre-specified sites from the CR9108963 placebo, 200mg, 300mg and 400mg dose groups will be included in this study.

• Study Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

• Denmark
  • Ballerup, Denmark, 2750
    • GSK Investigational Site
• Norway
  • Bergen, Norway, 5094
    • GSK Investigational Site
  • Hamar, Norway, 2317
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study population for CR9112792 will include approximately 145 postmenopausal women of those enrolled in study CR9108963, identified from subjects willing to participate and meeting eligibility criteria at pre-specified sites.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ronacaleret; Subjects receiving ronacaleret (200mg,300mg or 400mg) in study CR9108963 will be enrolled into this study.	Procedure: DXA; CR9112792 is a follow-up study of CR9108963, in which the effects of ronacaleret (100mg, 200mg, 300mg, 400mg) on bone mineral density (BMD), safety and tolerability were evaluated in comparison with placebo and 2 active comparators, alendronate and teriparatide. In this study we will follow-up subjects between 6 and 12 months after they discontinued treatment with placebo or ronacaleret (200mg, 300mg, 400mg) to evaluate the potential for mineralization of bone following cessation of ronacaleret therapy, evaluating lumbar spine and hip BMD by DXA. There is no administration of drug in this study.
Placebo; Subjects receiving placebo in study CR9108963 will be enrolled into this study.	Procedure: DXA; CR9112792 is a follow-up study of CR9108963, in which the effects of ronacaleret (100mg, 200mg, 300mg, 400mg) on bone mineral density (BMD), safety and tolerability were evaluated in comparison with placebo and 2 active comparators, alendronate and teriparatide. In this study we will follow-up subjects between 6 and 12 months after they discontinued treatment with placebo or ronacaleret (200mg, 300mg, 400mg) to evaluate the potential for mineralization of bone following cessation of ronacaleret therapy, evaluating lumbar spine and hip BMD by DXA. There is no administration of drug in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4)	6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent change in BMD, as measured by DXA, at the total hip, trochanter and femoral neck	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	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	12 to 18 months from the month 6 CR9108963 DXA to the CR9112792 study visit

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 23, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (Estimate): May 1, 2009

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: bone mineral density; postmenopausal osteoporosis; calcium-sensing receptor antagonist; ronacaleret
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 112792