A Phase 4 interventional study of teriparatide in Osteoporosis and Atypical Femoral Fracture, sponsored by Susan L. Greenspan. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2017-12-12.
Sponsored by Susan L. Greenspan · Phase 4, Interventional, and Treatment
This open label comparison study examines the hypothesis that teriparatide given immediately following repair of an atypical subtrochanteric or diaphyseal femoral shaft fracture will enhance healing and improve bone mineral density compared to delayed treatment (after six months) with teriparatide or no treatment with teriparatide (patients who refuse therapy or for whom teriparatide is contraindicated). Patients with up-front teriparatide in addition will have greater quality of life measures and less pain compared to those with delayed or no therapy.
Up to 24 postmenopausal women with osteoporosis who have been on bisphosphonate therapy for one year or more at any point prior to fracture and have sustained an atypical subtrochanteric or diaphyseal fracture will be enrolled. Subjects randomized to the two intervention arms will self-administer a daily SQ injection of the study medication for 12 months. The primary objective is to demonstrate greater radiologic evidence of healing at 10 weeks in patients on immediate teriparatide compared to those on delayed teriparatide who receive therapy six months after fracture. Secondary end points include (1) radiologic healing at 2, 6, 24, and 46 weeks; (2) increased bone density at 6 and 12 months as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, and femoral neck; (3) quality of life improvements at 10 weeks and 6 months as assessed by quality of life questionnaire and pain score; and (4) differences in biochemical markers of bone turnover in patient with upfront therapy compared to patients with delayed therapy and patients who refuse therapy or for whom teriparatide is contraindicated.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 13 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Susan L. Greenspan is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Open label teriparatide given immediately following surgical repair of fracture
Drug: teriparatide
Open label teriparatide given six months following surgical repair of fracture
Drug: teriparatide
20 microgram once-daily subcutaneous injection
Also known as: Forteo
Radiologic Evidence of Bone Healing
The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.
Time frame: 6, 12 months of treatment
Radiologic Evidence of Healing
Number of participants with persistence of alignment as determined by a radiologist.
Time frame: at 10 weeks for immediate teriparatide group
Radiologic Healing
Time frame: at 2, 6, 24, and 48 weeks
Increased Bone Density
Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck
Time frame: at 6 and 12 months
Quality of Life Improvements
Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.
Time frame: at 12 months
Difference in Biochemical Markers of Bone Turnover
upfront therapy group compared to delayed therapy group and no therapy group
Time frame: intervals over 12-18 months depending on treatment group
| Milestone | Immediate Teriparatide | Delayed Teriparatide |
|---|---|---|
| Started | 7 | 6 |
| Completed | 7 | 5 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.
| units on a scale | Immediate Teriparatide | Delayed Teriparatide |
|---|---|---|
| 6 mo | 12.6 ± 0.6 | 11.2 ± 1.3 |
| 12 mo | 15.4 ± 0.4 | 13.2 ± 1.2 |
Number of participants with persistence of alignment as determined by a radiologist.
| Participants | Immediate Teriparatide | Delayed Teriparatide |
|---|---|---|
| Radiologic Evidence of Healing | 5 | 4 |
No measurements were reported for this outcome.
Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck
| percentage change in BMD | Immediate Teriparatide | Delayed Teriparatide |
|---|---|---|
| Spine-PA (6 months) | 2.1 ± 1.5 | -0.6 ± 1.3 |
| Spine-PA (12 months) | 2.8 ± 2.0 | 5.4 ± 2.8 |
| Total Hip (6 months) | -1.6 ± 1.5 | -0.8 ± 0.7 |
| Total Hip (12 months) | -0.3 ± 1.8 | 1.5 ± 2.7 |
| Femoral Neck (6 months) | -1.8 ± 2.1 | -2.7 ± 1.0 |
| Femoral Neck (12 months) | -2.5 ± 3.0 | -1.9 ± 3.6 |
| Distal 1/3 Radius (6 months) | -0.6 ± 1.9 | -0.7 ± 1.1 |
| Distal 1/3 Radius (12 months) | -1.9 ± 1.7 | -6.1 ± 2.1 |
Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.
| units on a scale | Immediate Teriparatide | Delayed Teriparatide |
|---|---|---|
| Physical functioning | 49.3 ± 6.5 | 65.0 ± 20.3 |
| Physical health limitations | 48.2 ± 9.1 | 68.8 ± 21.2 |
| Emotional health limitations | 75.0 ± 9.1 | 72.9 ± 19.7 |
| Energy/Fatigue | 54.5 ± 7.4 | 59.4 ± 15.0 |
| Emotional well-being | 80.7 ± 4.1 | 70.0 ± 9.1 |
| Social functioning | 92.9 ± 4.6 | 65.6 ± 23.6 |
| Pain | 72.9 ± 9.7 | 59.4 ± 21.2 |
| General health | 66.1 ± 6.2 | 67.2 ± 12.1 |
upfront therapy group compared to delayed therapy group and no therapy group
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Teriparatide | 0/7 (0%) | 3/7 (42.9%) | 5/7 (71.4%) |
| Delayed Teriparatide | 0/6 (0%) | 2/6 (33.3%) | 5/6 (83.3%) |
| Event | Immediate Teriparatide | Delayed Teriparatide |
|---|---|---|
| elective back surgerySurgical and medical procedures | 0/7 | 1/6 |
| Ewings SarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/7 | 1/6 |
| CellulitisInfections and infestations | 1/7 | 0/6 |
| Abnormal coagulation profileBlood and lymphatic system disorders | 1/7 | 0/6 |
| HematomaGeneral disorders | 1/7 | 0/6 |
| Event | Immediate Teriparatide | Delayed Teriparatide |
|---|---|---|
| thigh painMusculoskeletal and connective tissue disorders | 0/7 | 2/6 |
| deep vein thrombosisVascular disorders | 0/7 | 1/6 |
| gingivitisGeneral disorders | 0/7 | 1/6 |
| periodontal gum surgerySurgical and medical procedures | 0/7 | 1/6 |
| allergic rhinitisImmune system disorders | 0/7 | 1/6 |
| coronary artery diseaseVascular disorders | 0/7 | 1/6 |
| cardiac catheterizationSurgical and medical procedures | 0/7 | 1/6 |
| dizzinessGeneral disorders | 0/7 | 1/6 |
| varicella zosterInfections and infestations | 0/7 | 1/6 |
| FallMusculoskeletal and connective tissue disorders | 1/7 | 0/6 |
| Age, Continuous(years) | Immediate Teriparatide | Delayed Teriparatide | Total |
|---|---|---|---|
| Mean | 78.0 ± 8.660 | 69.8 ± 8.085 | 74.2 ± 9.094 |
| Sex: Female, Male(Participants) | Immediate Teriparatide | Delayed Teriparatide | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Immediate Teriparatide | Delayed Teriparatide | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 7 | 4 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Susan L. Greenspan