A Phase 4 interventional study of Teriparatide (FORTEO) and Placebos in Osteogenesis Imperfecta, sponsored by Oregon Health and Science University. Completed at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by Oregon Health and Science University · Phase 4, Interventional, and Treatment
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).
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.
85 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's enrollment of 79 is above the median of 26 across 59 interventional studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Once daily SQ administration of Teriparatide (FORTEO) 20 ug for 18 months
Drug: Teriparatide (FORTEO)
Daily SQ placebo for 18 months
Drug: Placebos
Teriparatide (FORTEO) 20mcg, subcutaneous injection, once daily
Also known as: FORTEO
Spine Bone Mineral Density (BMD)
bone density by dual energy xray absorptiometry
Time frame: baseline and 18 months
Total Hip BMD
bone density by dual energy xray absorptiometry
Time frame: baseline and 18 months
| Milestone | Teriparatide (FORTEO) | Placebo |
|---|---|---|
| Started | 38 | 40 |
| Completed | 29 | 27 |
| Not completed | 9 | 13 |
| Withdrew: Withdrawal by subject | 3 | 4 |
| Withdrew: Protocol violation | 3 | 1 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Scan not analyzable | 3 | 6 |
bone density by dual energy xray absorptiometry
| percentage of change in g/cm2 | Teriparatide (FORTEO) | Placebo |
|---|---|---|
| Spine Bone Mineral Density (BMD) | 6.1 ± 1.5 | 2.8 ± 1.3 |
bone density by dual energy xray absorptiometry
| percentage of change in g/cm2 | Teriparatide (FORTEO) | Placebo |
|---|---|---|
| Total Hip BMD | 2.6 ± 2 | -2.4 ± 1.8 |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Teriparatide (FORTEO) | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Placebo | 1/40 (2.5%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | Teriparatide (FORTEO) | Placebo | Total |
|---|---|---|---|
| Mean | 40.8 ± 12.9 | 41.2 ± 10.1 | 41 ± 11.5 |
| Sex: Female, Male(Participants) | Teriparatide (FORTEO) | Placebo | Total |
|---|---|---|---|
| Female | 22 | 24 | 46 |
| Male | 16 | 16 | 32 |
| Race and Ethnicity Not Collected(Participants) | Teriparatide (FORTEO) | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University