CR9112792, a Follow-up of Study CR9108963 - Full Text View

Purpose

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.

Condition	Intervention
Osteoporosis	Procedure: DXA

Study Type:	Observational
Study Design:	Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Minerals Osteoporosis

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) [ Time Frame: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change in BMD, as measured by DXA, at the total hip, trochanter and femoral neck [ Time Frame: 6 to 12 months from the final CR9108963 DXA to the CR9112792 study visit ] [ Designated as safety issue: No ]
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) and total hip, trochanter and femoral neck [ Time Frame: 16 to 25 months from the screening CR9108963 DXA to the CR9112792 study visit ] [ Designated as safety issue: No ]
Percent change in BMD, as measured by DXA, at the lumbar spine (L1-L4) and total hip, trochanter and femoral neck [ Time Frame: 12 to 18 months from the month 6 CR9108963 DXA to the CR9112792 study visit ] [ Designated as safety issue: No ]

Enrollment:	171
Study Start Date:	March 2009
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Groups/Cohorts

Assigned Interventions

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.

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891553

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00891553 History of Changes
Other Study ID Numbers:	112792
Study First Received:	April 23, 2009
Last Updated:	February 21, 2013
Health Authority:	Argentina: Ministry of Health - A.N.M.A.T Norway: Statens Legemiddelverk Denmark: Lægemiddelstyrelsen Hong Kong: Department of Health South Africa: Medicines Control Council Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK United States: Food and Drug Administration Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

bone mineral density
calcium-sensing receptor antagonist
ronacaleret
postmenopausal osteoporosis

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013