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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00130403




Registration number
NCT00130403
Ethics application status
Date submitted
12/08/2005
Date registered
15/08/2005
Date last updated
11/01/2011

Titles & IDs
Public title
OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women
Scientific title
Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide
Secondary ID [1] 0 0
EudraCT # :2004-002317-37
Secondary ID [2] 0 0
HMR4003B_4034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis, Postmenopausal 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - risedronate sodium

Treatment: Drugs: risedronate sodium


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare the PTH-associated change from baseline at Month 3 of procollagen peptide P1NP, in subjects previously treated with Risedronate or Alendronate
Timepoint [1] 0 0
at Month 3
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
at 0.5, 1, 2, 3, 4, 5, 6, & 12 months of treatment
Secondary outcome [2] 0 0
Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Lumbar spine & hip BMD measured by DXA
Timepoint [2] 0 0
after 6 & 12 months of treatment
Secondary outcome [3] 0 0
Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Bone quality parameters captured by central quantitative computed tomography (QCT)
Timepoint [3] 0 0
after 12 months of treatment

Eligibility
Key inclusion 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
Minimum age
55 Years
Maximum age
85 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis, Australia - Cove
Recruitment postcode(s) [1] 0 0
- Cove
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Belgium
State/province [2] 0 0
Diegem
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
Netherlands
State/province [5] 0 0
Gouda
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Procter and Gamble
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT00130403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suzanne Meeves, PharmD, MBA
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications