Clinical trial NCT02598934: A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
Official title: A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-06
Enrollment: 308
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.


Eligibility criteria: Inclusion Criteria:

* Women newly diagnosed with postmenopausal osteoporosis
* Naive to prior bisphosphonate therapy

Exclusion Criteria:

* Inability to stand or sit upright for at least 60 minutes
* Inability to swallow a tablet whole
* Hypersensitivity to any component of ibandronate
* Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
* Other osteoporosis drug within last 3 months
* Malignant disease diagnosed within previous 10 years, except resected basal cell cancer

Primary outcomes:
measure: Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
timeFrame: Baseline, Month 6
measure: Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
timeFrame: Baseline, Month 6
measure: Percent Change From Baseline to Month 6 in Serum Osteocalcin
timeFrame: Baseline, Month 6
measure: Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
timeFrame: Baseline, Month 6
measure: Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
city: Montgomery
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Peoria
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Pine Bluff
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Wilmington
country: United States
state: Delaware
city: Deland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Palm Habor
country: United States
state: Florida
city: Palm Springs
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Rome
country: United States
state: Georgia
city: Morton Grove
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Waterloo
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Hagerstown
country: United States
state: Maryland
city: Reistertown
country: United States
state: Maryland
city: Olive Branch
country: United States
state: Mississippi
city: Jefferson City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Bloomfield
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Morehead City
country: United States
state: North Carolina
city: Morganton
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Doylestown
country: United States
state: Pennsylvania
city: Langhorne
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Mount Pleasant
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Morristown
country: United States
state: Tennessee
city: Murfreesboro
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Texarkana
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
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_CHAIR
References: