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NCT01155232Active, not recruiting

Effects of Teriparatide (PTH) on Bone in Men and Women With Osteoporosis

Effect of 24 Months of Teriparatide Therapy on Bone Microarchitecture and Bone Volume in Men and Women With Osteoporosis

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

Teriparatide (PTH) 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 may decrease after 20 months of therapy. However, bone biopsies of the pelvis done on people taking teriparatide show 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 radius and tibia in men and women with osteoporosis who receives 24 months of teriparatide therapy. The investigators believe that this new approach of measuring bone strength will help us better understand the mechanisms of therapeutic efficacy of teriparatide. In addition, measuring indices of bone strength such as the material composition (bone mineral content or BMD) and structural properties of bone (size and shape, and microarchitecture) may provide more data about the mechanisms of how teriparatide treatment can decrease fracture risk. In the end, this data will benefit and improve patient care by allowing us to show patients and their providers that whether BMD increases, decreases or stay the same, there are changes in their bone geometric structure with teriparatide therapy that increases bone strength.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
29 Jun 2010
Start date
1 Nov 2004
Primary completion date
31 Jan 2027
Lead sponsor
University Health Network, Toronto
Diseases
Osteoporosis
NCT number
NCT01155232

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 1 Nov 2004 to the primary completion date, 31 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
  • Ability to obtain teriparatide (not supplied by study sponsor)

Sex: All · 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.