Teriparatide (PTH) and Bone Strength in Postmenopausal Women

NCT01155245 | Active Not Recruiting

• 1 other identifier: 08-0321
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effects on bone quality of a medication (Teriparatide) used to treat people with severe osteoporosis. Teriparatide is the only bone formation therapy that has been approved for the treatment of postmenopausal osteoporosis in Canada. Osteoporosis is currently diagnosed using a bone mineral density (BMD) scan, which measures the amount of mineral (calcium etc) in bones (the higher the amount of mineral, the lower the fracture risk). Although BMD is linked to bone strength and is used to measure fracture risk, it does not give information on bone structure (called bone geometry) which can also tell us a great deal about fracture risks. Clinical trials have shown that teriparatide increases BMD at the lumbar spine and total hip, while BMD at the forearm decreases after 20 months of therapy. Whether this decrease of BMD at the forearm suggests a higher risk of wrist fracture or a change in bone structure is unclear. Bone biopsies of the pelvis done on people taking teriparatide shows improvement of bone geometry (ie bone thickness and increased trabeculae (small interconnecting rods of bone), suggesting that a change in bone geometry at the wrist may be occurring as well. Currently, there is a new technology, high resolution pQCT (HR-pQCT) that can assess bone geometry without a biopsy. Since bone strength is affected both by BMD and bone structure (as well as other material properties), our group is interested in examining changes in bone geometry at the forearm (a non-weight bearing site) and ankle (a weight bearing site) in postmenopausal women with osteoporosis who receive 24 months of teriparatide therapy. The investigators believe that this new approach of measuring bone strength will help us better understand whether teriparatide has different effects at different bone sites.

Conditions

Osteoporosis

Keywords

osteoporosis; HR-pQCT; PTH

Outcome Measures

Primary Outcomes (1)

• Change in cortical thickness with teriparatide therapy from baseline to 24 months

  0 to 24 months

Secondary Outcomes (1)

• Change in cortical thickness with teriparatide therapy from baseline to 48 months

  0 to 48 months

Study Arms (2)

Forteo (teriparatide)

postmenopausal women with osteoporosis

Drug: Forteo

Forteo (teriparatide) with AFF

Women with atypical femur fractures

Drug: Forteo

Interventions

Forteo DRUG

Forteo pen

Forteo (teriparatide); Forteo (teriparatide) with AFF

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community dwelling postmenopausal women with osteoporosis and women with atypical femur fractures

You may qualify if:

• History of fragility fracture OR
• High risk for fractures OR
• Very low BMD (T-score ≤ -2.5) OR
• Failed or intolerant to bisphosphonates
• Baseline serum levels of calcium, urate, ALP, PTH, creatinine and 25-hydroxyvitamin D \[25(OH)D\] must be within acceptable normal limits

You may not qualify if:

• History of skeletal irradiation
• Those at increased risk for osteosarcoma
• Diagnosis of Paget's disease
• History of primary hyperparathyroidism
• Significant renal impairment
• Vitamin D deficiency
• On steroids or have other causes of secondary osteoporosis

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University Health Network, TGH

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Angela MW Cheung, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2008
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

CA (1)