Clinical trial NCT00303485: A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
Official title: A Randomized, Double-blind, Placebo-controlled Study to Determine Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once Monthly Ibandronate in the Treatment of Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 67
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
* naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.

Exclusion Criteria:

* patients on hormone replacement therapy (HRT) within the last 3 months;
* patients on other osteoporosis medication within the last 3 months;
* sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
* hypersensitivity to any component of ibandronate;
* contraindication for calcium or vitamin D therapy;
* history of major gastrointestinal upset;
* malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).

Primary outcomes:
measure: Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3
timeFrame: Baseline (Visit 1) and Day 3
Secondary outcomes:
measure: Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
timeFrame: Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6
measure: Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
timeFrame: Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6
measure: Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments
timeFrame: Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7
measure: Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
timeFrame: Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6
measure: Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
timeFrame: Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
measure: Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
timeFrame: Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
measure: Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations
timeFrame: Day (D)7, D14, D21 and D28 of Month 6
measure: Number of Participants With Any Marked Abnormality in Laboratory Parameters
timeFrame: Up to 7 months
measure: Number of Participants With Any Adverse Event or Serious Adverse Event
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Augusta
country: United States
state: Georgia
city: Woodbury
country: United States
state: Minnesota
city: Bronx
country: United States
state: New York
city: Hopwood
country: United States
state: Pennsylvania
city: Madison
country: United States
state: Wisconsin
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: