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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489918
• Other study ID #: CP-2006-001
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: July 2018
• Source: Zosano Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• teriparatide
Macroflux® patch applied to the abdomen for 30 minutes daily
• teriparatide
FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zosano Pharma Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Absolute Change in Lumbar Spine BMD: Baseline to Week 12	Absolute Change in Lumbar Spine BMD from Baseline to Week 12	12 weeks
Secondary	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
Secondary	Percent Change in Femoral Neck BMD: Baseline to Week 24	Percent Change in Femoral Neck BMD from Baseline to Week 24	24 Weeks