NCT00489918

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
10 years until next milestone

Results Posted

Study results publicly available

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

June 19, 2007

Results QC Date

September 26, 2016

Last Update Submit

July 3, 2018

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    12 weeks

  • Absolute Change in Lumbar Spine BMD: Baseline to Week 12

    12 weeks

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

    24 Weeks

  • Percent Change in Femoral Neck BMD: Baseline to Week 24

    24 Weeks

Study Arms (5)

Macroflux® placebo

PLACEBO COMPARATOR

Macroflux® placebo patch

Drug: teriparatide

Macroflux® 20 mcg

EXPERIMENTAL

Macroflux® 20 mcg patch

Drug: teriparatide

Macroflux® 30 mcg

EXPERIMENTAL

Macroflux® 30 mcg patch

Drug: teriparatide

Macroflux® 40 mcg

EXPERIMENTAL

Macroflux® 40 mcg patch

Drug: teriparatide

FORTEO®

ACTIVE COMPARATOR

FORTEO® 20 mcg injection

Drug: teriparatide

Interventions

teriparatideDRUG

Macroflux® patch applied to the abdomen for 30 minutes daily

Also known as: PTH(1-34)
Macroflux® 20 mcgMacroflux® 30 mcgMacroflux® 40 mcgMacroflux® placebo

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cosman F, Lane NE, Bolognese MA, Zanchetta JR, Garcia-Hernandez PA, Sees K, Matriano JA, Gaumer K, Daddona PE. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. J Clin Endocrinol Metab. 2010 Jan;95(1):151-8. doi: 10.1210/jc.2009-0358. Epub 2009 Oct 26.

    PMID: 19858319DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

TeriparatideParathyroid Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Don Kellerman, VP of Clinical Development and Medical Affairs
Organization
Zosano Pharma Inc.
dkellerman@zosanopharma.com
(510) 745-4004

Study Officials

  • Thorsten von Stein, MD, Ph.D

    Zosano Pharma Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 21, 2007

Study Start

June 1, 2007

Primary Completion

April 1, 2008

Study Completion

August 1, 2008

Last Updated

July 31, 2018

Results First Posted

July 31, 2018

Record last verified: 2018-07