Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication FORTEO is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures. FDA label
Also known as teriparatide, LY333334, FORSTEO, Subcutaneous Teriparatide, recombinant human parathyroid hormone (rhPTH) (1-34), recombinant human teriparatide, Teriparatide (PTH 1-34), Group 1
FORTEO · 22 trials · 13 indications
Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Number of subjects with complaints after 8 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Summary of number of complaints, and common complaints (at least 3% complaint rate), from subjects using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Number of subjects with complaints after 46 weeks, and common complaints (at least 3% complaint rate), using Forteo B Pen. Functional Complaints were related to device malfunction; Nonfunctional were related to either cosmetic or perception concerns.
Least Squares (LS) Means were adjusted for age, baseline serum aminoterminal propeptide of Type I procollagen (P1NP), fracture less than 12 months before study start, duration of prior bisphosphonate use, screening glucocorticoid dose, and cumulative glucocorticoid dose before and during the trial.
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.
24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.
Analysis using Regional Cartilage Volume Segmentation
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 millimeter \[mm\]).
Number of evaluation points (patches) showing defined Draize score. Erythema and edema were used to determine skin irritation and sensitization. Score 0 = No Erythema/Edema; Score 1 = Very slight Erythema/Edema (barely perceptible); Score 2 = Well defined Erythema/Edema (edges of area well defined by definite raising); Score 3 = Moderate to Severe Erythema/Edema (raised approximately 1 mm); Score 4 = Severe Edema (raised more than 1 mm and extending beyond area of exposure).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Administered once daily by subcutaneous (SC) injection for 6 months |
| Teriparatide | EXPERIMENTAL | 20 microgram (µg) administered once daily by SC injection for 6 months |
| Risedronate | ACTIVE_COMPARATOR | Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW) |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | LY333334 40 micrograms/day plus calcium and vitamin D |
| 2 | EXPERIMENTAL | LY333334 20 micrograms/day plus calcium and vitamin D |
| 3 | PLACEBO_COMPARATOR | Placebo plus calcium and vitamin D |
| Women with Idiopathic osteoporosis (IOP) | EXPERIMENTAL | Each subject will receive 20 micrograms of Teriparatide (PTH 1-34) subcutaneously daily for 18 -24 months |
| 50 mcg | EXPERIMENTAL | ViaDerm transdermal delivery |
| 80 mcg | EXPERIMENTAL | Add Via-Derm transdermal delivery |
| 20 mcg | ACTIVE_COMPARATOR | Subcutaneous injection |
| Group 1- Treatment | ACTIVE_COMPARATOR | 20 mcg dosage amounts of teriparatide, in the FDA approved form Forteo, manufactured by Lilly, LLC, are loaded into a 2.4 ml prefilled delivery device (multi injection pen) that administers 28 equal doses as subcutaneous injections in the thigh or abdominal wall. Subjects will inject themselves once a day for 24 weeks. |
| Group 2- Placebo | PLACEBO_COMPARATOR | Saline placebo is packaged by the manufacturer (Lilly, LLC) in the same 2.4 ml injection pen that is used for teriparatide; it will provide 28 doses of placebo. Subjects will inject themselves once a day for 24 weeks. |
| 20 mcg Subcutaneous Teriparatide | ACTIVE_COMPARATOR | Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner. |
| 30 mcg Transdermal Teriparatide | EXPERIMENTAL | Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| 50 mcg Transdermal Teriparatide | EXPERIMENTAL | Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| 80 mcg Transdermal Teriparatide | EXPERIMENTAL | Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level. |
| FORTEO | EXPERIMENTAL | - |
| LY333334 + placebo | EXPERIMENTAL | Part A: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days Part B: Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks Rest phase: 2 weeks with no patch application Challenge phase: 80 microgram active patch given once for at least 6 hours |
| Name | Type | Description |
|---|---|---|
| Teriparatide | DRUG | Administered by SC injection |
| Placebo | DRUG | Administered by SC injection |
| Calcium supplementation | DIETARY_SUPPLEMENT | Administered orally |
| Vitamin D supplementation | DIETARY_SUPPLEMENT | Administered orally |
| Risedronate | DRUG | 35 mg/week po for 18 months |
| Salmon Calcitonin | DRUG | Intranasal, 200 International Units (IU)/day, 24 weeks |
| Alendronate Sodium | DRUG | 10 mg/day, oral, 36 months |
| Calcium Supplement | DRUG | Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement |
| Vitamin D Supplement | DRUG | Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement |
| raloxifene | DRUG | - |
| Teriparatide (PTH 1-34) | DRUG | 20 micrograms subcutaneous injection daily |
| Subcutaneous Teriparatide | DRUG | Administered subcutaneously once daily for 12 months |
| Transdermal Teriparatide | DRUG | Administered transdermally, applied once daily for 6 hours over 12 months |
| Periodontal surgery | PROCEDURE | - |
| FORTEO | DRUG | parathyroid hormone; self-administration for 6 weeks |
| Vitamin D and Calcium | DIETARY_SUPPLEMENT | PO, QD, for six weeks |
| LY333334 | DRUG | Transdermal patch |
Inclusion Criteria: * Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced) * Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 ye...
FORTEO is being studied for bone loss, including bone loss associated with periodontitis. It is an investigational therapy in Phase 1 clinical development. Eli Lilly and Company is the developer. The research focuses on its effects on bone in the oral cavity and related bone loss conditions.
FORTEO is developed by Eli Lilly and Company, which trades under the ticker LLY. The company is the sponsor of the clinical program evaluating FORTEO for bone loss. Lilly is a global pharmaceutical company headquartered in Indianapolis, Indiana.
FORTEO is in Phase 1 clinical development. It is an investigational therapy and has not been approved for the bone loss indication described here. The Phase 1 program has completed one trial with 40 enrolled participants. Further clinical development would be required before any regulatory review.
FORTEO has been evaluated in the Phase 1 trial NCT00277706, titled Impact of Parathyroid Hormone (PTH) on Osseous Cavity. The trial enrolled 40 participants in the United States and studied bone loss and periodontitis. It was randomized, double-blind, and placebo-controlled, and it is now completed.
FORTEO is a small molecule therapy. It is being investigated for its effects on bone loss, including bone loss related to periodontitis. The completed Phase 1 trial examined parathyroid hormone and its impact on the osseous cavity. The program targets endocrine-related bone loss mechanisms.