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

Phase 2

Completed

• Conditions: Osteoporosis
• Interventions: Drug: teriparatide

• Registration Number: NCT00489918
• Lead Sponsor: Zosano Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-19
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Primary Completion: 2008-04
• Study Completion: 2008-08
• Results First Submitted: 2016-09-26
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-03
• Last Update Submitted: 2018-07-03
• Results First Posted: 2018-07-31
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macroflux® 20 mcg	teriparatide	Macroflux® 20 mcg patch
Macroflux® placebo	teriparatide	Macroflux® placebo patch
Macroflux® 40 mcg	teriparatide	Macroflux® 40 mcg patch
Macroflux® 30 mcg	teriparatide	Macroflux® 30 mcg patch
FORTEO®	teriparatide	FORTEO® 20 mcg injection

Primary Outcome Measures

Name	Time	Method
Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24	24 weeks	Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Percent Change in Femoral Neck BMD: Baseline to Week 24	24 Weeks	Percent Change in Femoral Neck BMD from Baseline to Week 24
Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12	12 weeks	Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12
Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24	24 Weeks	Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24
Absolute Change in Lumbar Spine BMD: Baseline to Week 12	12 weeks	Absolute Change in Lumbar Spine BMD from Baseline to Week 12