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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
165 participants (actual)
Sponsor
Zosano Pharma Corporation · Industry
Design
Randomized · Quadruple masking
Countries
Not stated
Start
Jun 2007
Primary completion
Apr 2008
Completion
Aug 2008
First posted
21 Jun 2007 (estimated)
Last update posted
31 Jul 2018
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 2

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

    NCT00489918

    Jun 2007 to Aug 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • teriparatideDrug
  • teriparatideDrug

Arms5

  • Placebo comparator

    Macroflux® placebo

    Macroflux® placebo patch

  • Experimental

    Macroflux® 20 mcg

    Macroflux® 20 mcg patch

  • Experimental

    Macroflux® 30 mcg

    Macroflux® 30 mcg patch

  • Experimental

    Macroflux® 40 mcg

    Macroflux® 40 mcg patch

  • Active comparator

    FORTEO®

    FORTEO® 20 mcg injection

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24

    Time frame · 24 weeks

    Registry description

    Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24

Secondary outcomes(4)
  1. Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12

    Time frame · 12 weeks

    Registry description

    Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12

  2. Absolute Change in Lumbar Spine BMD: Baseline to Week 12

    Time frame · 12 weeks

    Registry description

    Absolute Change in Lumbar Spine BMD from Baseline to Week 12

  3. Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24

    Time frame · 24 Weeks

    Registry description

    Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24

  4. Percent Change in Femoral Neck BMD: Baseline to Week 24

    Time frame · 24 Weeks

    Registry description

    Percent Change in Femoral Neck BMD from Baseline to Week 24

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 24 weeks

Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24

GroupValue (percent change)Spread
Macroflux® Placebo-0.333.467
Macroflux® 20 mcg2.963.524
Macroflux® 30 mcg3.473.575
Macroflux® 40 mcg4.974.114
FORTEO®3.553.730
Secondary and other outcome results(4)
Secondary outcomeMean· 12 weeks

Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12

GroupValue (Percent change)Spread
Macroflux® Placebo0.973.312
Macroflux® 20 mcg1.552.606
Macroflux® 30 mcg2.043.277
Macroflux® 40 mcg2.52.86
FORTEO®2.812.771
Secondary outcomeMean· 12 weeks

Absolute Change in Lumbar Spine BMD: Baseline to Week 12

GroupValue (g/cm^2)Spread
Macroflux® Placebo0.0070.0234
Macroflux® 20 mcg0.0110.0191
Macroflux® 30 mcg0.0140.0238
Macroflux® 40 mcg0.0170.0285
FORTEO®0.0210.0201
Secondary outcomeMean· 24 Weeks

Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24

GroupValue (Percent change)Spread
Macroflux® Placebo-0.6341.9719
Macroflux® 20 mcg0.1382.0386
Macroflux® 30 mcg0.5532.3694
Macroflux® 40 mcg1.3312.1111
FORTEO®0.0942.6194
Secondary outcomeMean· 24 Weeks

Percent Change in Femoral Neck BMD: Baseline to Week 24

GroupValue (Percent change)Spread
Macroflux® Placebo0.1723.3432
Macroflux® 20 mcg0.9493.2975
Macroflux® 30 mcg0.5992.6127
Macroflux® 40 mcg0.7502.6132
FORTEO®-0.0123.6600

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Macroflux® PlaceboMacroflux® placebo patch teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily–1 / 3329 / 33
Macroflux® 20 mcgMacroflux® 20 mcg patch teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily–1 / 3432 / 34
Macroflux® 30 mcgMacroflux® 30 mcg patch teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily–0 / 3231 / 32
Macroflux® 40 mcgMacroflux® 40 mcg patch teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily–0 / 3330 / 33
FORTEO®FORTEO® 20 mcg injection teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh–0 / 3323 / 33

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

7 results

Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women.

Cosman et al. 2010The Journal of clinical endocrinology and metabolismcited by 87

PMID 19858319PMC2805490DOI 10.1210/jc.2009-0358PUB-19858319

Rights unknown7 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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;

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