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NCT01155245Active, not recruiting

Teriparatide (PTH) and Bone Strength in Postmenopausal Women

Study on the Effect of 24 Months of Teriparatide Therapy on Bone Microarchitecture and Bone Volume in Postmenopausal Women With Osteoporosis

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
29 Jun 2010
Start date
Jun 2008
Primary completion date
Jan 2027
Lead sponsor
University Health Network, Toronto
Diseases
Osteoporosis
NCT number
NCT01155245

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From Jun 2008 to the primary completion date, Jan 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • On steroids or have other causes of secondary osteoporosis

Other illness

  • History of skeletal irradiation
  • Diagnosis of Paget's disease
  • History of primary hyperparathyroidism
  • Significant renal impairment

Other

  • Those at increased risk for osteosarcoma
  • Vitamin D deficiency

Who the study is looking for

  • 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

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Health Network/TGH
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.