Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis

Study Overview
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Brief Summary
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A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis

Official Title
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A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: teriparatide
* Drug: teriparatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy postmenopausal women age 50 years or older At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray absorptiometry (DXA) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, AND a T-score of at least < -1.0 at the lumbar spine; or A T-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral fracture; Exclusion Criteria: Active hepatitis; Active pancreatitis; Unstable cardiac disease; Unstable pulmonary disease; Celiac disease; Hyper- or hypo-parathyroidism; Hyperthyroidism; Cushing's disease; Osteomalacia; Paget's disease; Osteogenesis imperfecta; Known blood disorders; History of kidney stones; Impaired renal function; Autoimmune diseases; Bone metastases or a history of skeletal malignancies; Cancer history that includes any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for at least 1 year from the time of original resection; Any condition or disease that may interfere with the ability to have or the evaluation of a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or >1 lumbar vertebral fracture in L1-L4; More than 4 vertebral fractures in T4-L4; Bilateral hip replacements; Use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time; Have received methotrexate or immunomodulatory agents with antiproliferative activity; With known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis; With known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its analogs, or components of the Macroflux® systems; Who, in the opinion of the investigator, should not participate in the study, or may not be capable of following the study schedule for any reason; and Unwillingness or inability to abide by the requirements of the study. Have received any intravenous (IV) administered bisphosphonates in the past 24 months, or >2 doses of IV administered bisphosphonates total; Use of oral bisphosphonates before randomization, including investigational bisphosphonates, unless: <6 months of treatment and off for 6 months, or 6-12 months of treatment and off for 2 years, or >12 months of treatment and off for 5 years;

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Macroflux® placebo<br>Macroflux® placebo patch | Drug: teriparatide<br>* Macroflux® patch applied to the abdomen for 30 minutes daily<br>* Other names: PTH(1-34);|
| Experimental: Macroflux® 20 mcg<br>Macroflux® 20 mcg patch | Drug: teriparatide<br>* Macroflux® patch applied to the abdomen for 30 minutes daily<br>* Other names: PTH(1-34);|
| Experimental: Macroflux® 30 mcg<br>Macroflux® 30 mcg patch | Drug: teriparatide<br>* Macroflux® patch applied to the abdomen for 30 minutes daily<br>* Other names: PTH(1-34);|
| Experimental: Macroflux® 40 mcg<br>Macroflux® 40 mcg patch | Drug: teriparatide<br>* Macroflux® patch applied to the abdomen for 30 minutes daily<br>* Other names: PTH(1-34);|
| Active Comparator: FORTEO®<br>FORTEO® 20 mcg injection | Drug: teriparatide<br>* FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh<br>* Other names: FORTEO®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 | Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 | Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12 | 12 weeks | 
| Absolute Change in Lumbar Spine BMD: Baseline to Week 12 | Absolute Change in Lumbar Spine BMD from Baseline to Week 12 | 12 weeks | 
| Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24 | Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24 | 24 Weeks | 
| Percent Change in Femoral Neck BMD: Baseline to Week 24 | Percent Change in Femoral Neck BMD from Baseline to Week 24 | 24 Weeks |