CR9112792, a Follow-up of Study CR9108963

NCT00891553 | Completed

• 1 other identifier: 112792
• Study Type: observational
• Target: 171
• Locations: 2 countries
• Sites: 3

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 cessation of ronacaleret therapy.

Conditions

Osteoporosis

Keywords

bone mineral density; calcium-sensing receptor antagonist; ronacaleret; postmenopausal osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Ronacaleret

Subjects receiving ronacaleret (200mg,300mg or 400mg) in study CR9108963 will be enrolled into this study.

Procedure: DXA

Placebo

Subjects receiving placebo in study CR9108963 will be enrolled into this study.

Procedure: DXA

Interventions

DXA PROCEDURE

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; Ronacaleret

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Ballerup Municipality, 2750, Denmark

Location

GSK Investigational Site

Bergen, 5094, Norway

Location

GSK Investigational Site

Hamar, 2317, Norway

Location

MeSH Terms

Conditions

Osteoporosis; Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: May 1, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

DK (1); NO (2)