Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta (OI)
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| ClinicalTrials.gov Identifier: NCT00131469 |
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Recruitment Status :
Completed
First Posted : August 18, 2005
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteogenesis Imperfecta | Drug: Teriparatide (FORTEO) Drug: Placebos | Phase 4 |
The purpose of this study is to determine the effectiveness of teriparatide (FORTEO), which is human parathyroid hormone 1-34, for increasing bone mass and improving bone structure in adults affected with Osteogenesis Imperfecta (OI). Osteogenesis imperfecta is an inherited disorder of type I collagen, a major component of bones, and is characterized by multiple fractures and deformities. OI affects approximately 1-2 of every 10,000 individuals. Virtually all of the studies of potential treatments for OI have evaluated the effects of medications only on children with OI. There is no cure for osteogenesis imperfecta and there is no established medical therapy for adults with the disorder. There are very limited data concerning the usefulness of parathyroid hormone therapy in OI. An effective anabolic therapy for the treatment of adult patients with OI could be a valuable asset to the affected patients. In this study, the working hypothesis is that individuals affected with OI who are treated with Forteo will experience increased spine and hip bone mineral density and an increase in bone strength. Although Forteo is not expected to change the defect in the collagen produced, but is postulated to increase the quantity of bone formed and improve bone strength.
This will be a placebo controlled, double blinded trial; half the patients will receive Forteo 20 ug/day SQ. Adult patients (age at least 18 yrs) with OI will be enrolled for a treatment duration of 18 months. Blood, urine, and bone density/strength tests will be done during the study to assess efficacy and safety.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 79 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI) |
| Study Start Date : | June 2005 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Teriparatide (FORTEO)
Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months
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Drug: Teriparatide (FORTEO)
Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
Other Name: FORTEO |
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Placebo Comparator: Placebo
Daily SQ placebo for 18 months
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Drug: Placebos |
- Spine Bone Mineral Density (BMD) [ Time Frame: baseline and 18 months ]bone density by dual energy xray absorptiometry
- Total Hip BMD [ Time Frame: baseline and 18 months ]bone density by dual energy xray absorptiometry
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous established diagnosis of Osteogenesis Imperfecta AND
- > 2 previous adult fractures, AND/OR
- BMD at lumbar spine, femoral neck or total hip T score < -2.0
Exclusion Criteria:
- Open epiphyses.
- History of external beam radiation to the skeleton.
- Pagets disease.
- Bone metastases or skeletal malignancies.
- Total lifetime exposure to any antiresorptive medication < 90 days (Primary Inclusion).
- Treatment with any antiresorptive medication 12 months proceeding enrollment - (Secondary Inclusion).
- Women with OI who are pregnant or unwilling to use 1 form of contraception.
- Vitamin D insufficiency (25-hydroxyvitamin D <15ng/ml)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131469
| United States, Maryland | |
| Kennedy Krieger Institute | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Oregon | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Texas | |
| Baylor College of Medicine, Department of Molecular and Human Gentics | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Eric S Orwoll, M.D. | Oregon Health and Science University | |
| Principal Investigator: | Jay Shapiro, M.D. | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | |
| Principal Investigator: | Brendan Lee, M.D., PhD | Balor College of Medicine | |
| Principal Investigator: | Sandra Veith, CRA | Oregon Health and Science University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eric Orwoll, MD, Professor Of Medicine, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00131469 |
| Other Study ID Numbers: |
IBMD-OI UL1RR024140 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 18, 2005 Key Record Dates |
| Results First Posted: | April 24, 2019 |
| Last Update Posted: | April 24, 2019 |
| Last Verified: | April 2019 |
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Osteogenesis Imperfecta Brittle Bone Disease Fragility Fractures |
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Osteogenesis Imperfecta Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Genetic Diseases, Inborn |
Collagen Diseases Connective Tissue Diseases Teriparatide Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents |