OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women

Osteoporosis, Postmenopausal Clinical Trial

Official title:

Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130403
• Other study ID #: HMR4003B_4034
• Secondary ID: EudraCT # :2004-
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2005
• Last updated: January 10, 2011
• Start date: March 2004
• Est. completion date: March 2007

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.

Description:

All subjects will be treated with teriparatide (human, recombinant PTH[1-34])(human, recombinant PTH[1-34]), 20 microgram subcutaneously daily for 12 months. Subjects will consist of 290 postmenopausal women previously treated with either risedronate or alendronate for at least 24 months. An approximately equal number of subjects will have been previously treated with risedronate and alendronate, and the subjects will be balanced with regard to duration of previous treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 85 Years

Eligibility

ELIGIBILITY CRITERIA include:

• Post-menopausal women who have used risedronate or alendronate continuously for at least 24 mos prior to enrollment

• Dosing regimens allowable are continuous (ie, uninterrupted) daily or weekly formulations of risedronate (5 mg once daily [OD] or 35 or 30 mg once a week [OAW]) or alendronate (10 mg OD or 70 mg OAW), for a minimum of 24 months prior to enrollment into study

• Lumbar spine or total hip BMD T-score 1ess than or equal to -2.0 and >/= 1 prevalent osteoporotic fracture, or lumbar spine or total hip BMD T-score less than or equal to -2.5 with or without and >/= 1 prevalent osteoporotic fracture. The qualifying values must be documented prior to enrollment

• Vitamin D (25-hydroxyvitamin D) between 16 ng/ml and 80 ng/ml

• Urine NTX <50 nmol/mmol creatinine (to assure treatment compliance and bone turnover is in the pre-menopausal range)

EXCLUSION CRITERIA include:

• Impaired renal function, demonstrated by creatinine clearance < 30 ml/min

• Any condition or disease that may interfere with the evaluation of at least 2 lumbar vertebrae (not necessarily contiguous), determined in a screening radiograph by a radiologist at the central facility (eg, confluent aortic calcifications, severe osteoarthritis, spinal fusion, lumbar spine fractures)

• Depot injection vitamin D >10,000 IU in the past 9 months prior to starting the investigational product

• Treatment with antiresorptive agents other than risedronate, alendronate, and hormone replacement therapy within the last 36 months before study entry (ie, ibandronate, pamidronate, etidronate, raloxifene, clodronate, or zoledronate)

• Use of combination alendronate and risedronate, either simultaneously or sequentially, within 60 months prior to enrollment, or use of any anti-resorptive agent in combination with risedronate or alendronate

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• risedronate sodium

Locations

Country	Name	City	State
Australia	sanofi-aventis, Australia	Cove	New South Wales
Belgium	sanofi-aventis, Belgium	Diegem
Canada	sanofi-aventis, Canada	Laval	Quebec
France	sanofi-aventis, France	Paris
Netherlands	sanofi-aventis, Netherlands	Gouda
United Kingdom	sanofi-aventi, UK	Guildford	Surrey
United States	sanofi-aventis, US	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Procter and Gamble

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the PTH-associated change from baseline at Month 3 of procollagen peptide P1NP, in subjects previously treated with Risedronate or Alendronate		at Month 3	No
Secondary	Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: P1NP & other biomarkers including bone-specific alkaline phosphatase, osteocalcin, serum CTX, urine NTX		at 0.5, 1, 2, 3, 4, 5, 6, & 12 months of treatment	No
Secondary	Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Lumbar spine & hip BMD measured by DXA		after 6 & 12 months of treatment	No
Secondary	Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Bone quality parameters captured by central quantitative computed tomography (QCT)		after 12 months of treatment	No