Phase 2
N=165
Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00489918 ↗Enrolled (actual)
165
Serious AEs
1.2%
Results posted
Jul 2018
Primary outcome: Primary: Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 — -0.33; 2.96; 3.47; 4.97 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- teriparatide (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Zosano Pharma Corporation
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24 |
-0.33; 2.96; 3.47; 4.97; 3.55 | — |
| SECONDARY Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12 |
0.97; 1.55; 2.04; 2.5; 2.81 | — |
| SECONDARY Absolute Change in Lumbar Spine BMD: Baseline to Week 12 |
0.007; 0.011; 0.014; 0.017; 0.021 | — |
| SECONDARY Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24 |
-0.634; 0.138; 0.553; 1.331; 0.094 | — |
| SECONDARY Percent Change in Femoral Neck BMD: Baseline to Week 24 |
0.172; 0.949; 0.599; 0.750; -0.012 | — |
Summary
A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis
Eligibility Criteria
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 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: 12 months of treatment and off for 5 years;
Data sourced from ClinicalTrials.gov (NCT00489918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.