NCT00303485

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2006

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

May 2, 2016

Completed
Last Updated

May 2, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

March 16, 2006

Results QC Date

February 23, 2016

Last Update Submit

March 30, 2016

Conditions

Post Menopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3

    Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) \* 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.

    Baseline (Visit 1) and Day 3

Secondary Outcomes (9)

  • Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time

    Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6

  • Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time

    Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6

  • Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments

    Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7

  • 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

    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

  • Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL

    Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6

  • +4 more secondary outcomes

Study Arms (2)

Ibandronate

EXPERIMENTAL

Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.

Drug: Vitamin D and calcium supplementationDrug: ibandronate [Bonviva/Boniva]

Placebo

PLACEBO COMPARATOR

Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.

Drug: PlaceboDrug: Vitamin D and calcium supplementation

Interventions

PlaceboDRUG

po monthly for 6 months

Placebo
Vitamin D and calcium supplementationDRUG

As prescribed

IbandronatePlacebo
ibandronate [Bonviva/Boniva]DRUG

150mg po monthly for 6 months

Ibandronate

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

La Jolla, California, 92093, United States

Location

Unknown Facility

Augusta, Georgia, 30904, United States

Location

Unknown Facility

Woodbury, Minnesota, 55125, United States

Location

Unknown Facility

The Bronx, New York, 10461, United States

Location

Unknown Facility

Hopwood, Pennsylvania, 15445, United States

Location

Unknown Facility

Madison, Wisconsin, 53705, United States

Location

Unknown Facility

Ponce, 00717-1318, Puerto Rico

Location

Unknown Facility

San Juan, 00927, Puerto Rico

Location

Unknown Facility

San Juan, 00935, Puerto Rico

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Vitamin DIbandronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Results Point of Contact

Title
Roche Trial Information Hotline
Organization
F. Hoffmann-La Roche AG
global.trial_information@roche.com
+41 616878333

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

February 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

May 2, 2016

Results First Posted

May 2, 2016

Record last verified: 2016-03

Locations

US(7)PR(3)