Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
July 3, 2018 updated by: Zosano Pharma Corporation
A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis
A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Macroflux® placebo
Macroflux® placebo patch
|
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Names:
FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
Other Names:
|
|
Experimental: Macroflux® 20 mcg
Macroflux® 20 mcg patch
|
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Names:
FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
Other Names:
|
|
Experimental: Macroflux® 30 mcg
Macroflux® 30 mcg patch
|
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Names:
FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
Other Names:
|
|
Experimental: Macroflux® 40 mcg
Macroflux® 40 mcg patch
|
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Names:
FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
Other Names:
|
|
Active Comparator: FORTEO®
FORTEO® 20 mcg injection
|
Macroflux® patch applied to the abdomen for 30 minutes daily
Other Names:
FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24
Time Frame: 24 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
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
Time Frame: 24 Weeks
|
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
Time Frame: 24 Weeks
|
Percent Change in Femoral Neck BMD from Baseline to Week 24
|
24 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Thorsten von Stein, MD, Ph.D, Zosano Pharma Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
June 19, 2007
First Submitted That Met QC Criteria
June 20, 2007
First Posted (Estimate)
June 21, 2007
Study Record Updates
Last Update Posted (Actual)
July 31, 2018
Last Update Submitted That Met QC Criteria
July 3, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-2006-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.