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

NCT01155232 | Unknown

• 1 other identifier: 04-0655
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis

Keywords

osteoporosis; Forteo; Parathyroid hormone; HR-pQCT

Outcome Measures

Primary Outcomes (1)

• Change in cortical thickness at the radius and tibia as measured by high-resolution quantitative computer tomography (HR-pQCT)

  0-24 months

Study Arms (2)

Forteo (teriparatide)

postmenopausal women and men with osteoporosis Teriparatide is marketed as Forteo by Eli Lilly Teriparatide is not supplied (observational study)

Drug: Teriparatide

Forteo (teriparatide) in AFF

women who have experienced an atypical femur fracture (AFF) Teriparatide is not supplied (observational study)

Drug: Teriparatide

Interventions

Teriparatide DRUG

Forteo (teriparatide)pen daily for 24 months

Also known as: Teriparatide is a section of the parathyroid hormone (PTH) given by injection., The drug is marketed by Eli Lilly under the name of Forteo

Forteo (teriparatide); Forteo (teriparatide) in AFF

Eligibility Criteria

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

Study Population

community dwelling men and women with osteoporosis who have been prescribed teriparatide for severe osteoporosis. (Teriparatide is not supplied as part of this study)

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
• Ability to obtain teriparatide (not supplied by study sponsor)

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

Study Sites (1)

University Health Network, TGH

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

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 m Cheung, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Chang, RN

CONTACT

416-340-4800; jessica.chang@uhn.on.ca

Judite Scher, MSc CCRP

CONTACT

416-340-4841; jscher@uhnresearch.ca

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: November 1, 2004
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

CA (1)