Clinical trial NCT00557310: A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
Official title: The Effects of Teriparatide on Bone Microarchitecture as Determined by High Resolution Magnetic Resonance Imaging and Digital Topological Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis, Postmenopausal
Keywords: osteoporosis, teriparatide, postmenopausal, MRI, finite element analysis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 35
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.

Detailed description: As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

Eligibility criteria: Inclusion Criteria:

* postmenopausal (after the "change of life") women with osteoporosis
* between the ages of 45-85
* have low bone mass as determined by a bone density test
* have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites)
* could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate

Exclusion Criteria:

* have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study
* have a metal implant or have had a hip replacement in either hip which might affect results of study
* have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton
* currently have active or suspected diseases that affect the bone, other than osteoporosis
* have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values

Primary outcomes:
measure: Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint
timeFrame: Baseline, 18 months
Secondary outcomes:
measure: Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint
timeFrame: Baseline, 24 months
measure: Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint
timeFrame: Baseline, 18, 24 months
measure: Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint
timeFrame: Baseline, 18, 24 months
measure: Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint
timeFrame: Baseline, 18, 24 months
measure: Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint
timeFrame: Baseline, 3, 6, 12, 18, 24 months
measure: Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint
timeFrame: Baseline, 18 months
measure: Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint
timeFrame: Baseline, 18 months
measure: Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint
timeFrame: Baseline, 18 months
measure: Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint
timeFrame: Baseline, 18 months
measure: Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint
timeFrame: Baseline, 18, 24 months
measure: Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint
timeFrame: Baseline, 18, 24 months
measure: Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint
timeFrame: Baseline, 18, 24 months
measure: Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint
timeFrame: Baseline, 18, 24 months
measure: Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint
timeFrame: Baseline, 18, 24 months
measure: Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint
timeFrame: Baseline, 3, 6, 24 months
measure: Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint
timeFrame: Baseline, 3, 6, 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Lakewood
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Colorado
city: Omaha
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Nebraska
city: Albuquerque
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New Mexico
city: Pittsburgh
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Pennsylvania
city: Vancouver
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: British Columbia
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: