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

Condition(s) targeted: Osteoporosis, Postmenopausal

Intervention: risedronate sodium (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Suzanne Meeves, PharmD, MBA, Study Director, Affiliation: Sanofi

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.

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

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

Primary outcome: Compare the PTH-associated change from baseline at Month 3 of procollagen peptide P1NP, in subjects previously treated with Risedronate or Alendronate

Secondary outcome:

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

Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Lumbar spine & hip BMD measured by DXA

Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Bone quality parameters captured by central quantitative computed tomography (QCT)

Detailed 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.

Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Female.

Criteria:

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

sanofi-aventis, Belgium, Diegem, Belgium

sanofi-aventis, France, Paris, France

sanofi-aventis, Netherlands, Gouda, Netherlands

sanofi-aventis, US, Bridgewater, New Jersey 08807, United States

sanofi-aventis, Australia, Cove, New South Wales, Australia

sanofi-aventis, Canada, Laval, Quebec, Canada

sanofi-aventi, UK, Guildford, Surrey, United Kingdom

Starting date: March 2004
Last updated: January 10, 2011