NCT00086619

Brief Summary

Parathyroid hormone (PTH) increases bone formation and thereby improves bone density and bone strength in postmenopausal women with osteoporosis. However, prolonged PTH treatment increases bone formation less and less over time. This study will test whether increasing the daily dose of PTH sustains its ability to improve bone formation, and optional sub-studies will test several potential reasons why PTH's effects on bone formation decline over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2004

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

September 26, 2013

Completed
Last Updated

October 30, 2013

Status Verified

September 1, 2013

Enrollment Period

5.6 years

First QC Date

July 7, 2004

Results QC Date

June 7, 2012

Last Update Submit

September 26, 2013

Conditions

Postmenopausal OsteoporosisOsteoporosis

Keywords

OsteoporosisParathyroid hormoneTeriparatideBone formationBone resorption

Outcome Measures

Primary Outcomes (1)

  • Changes in Indices of Bone Turnover

    Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months\*ng/ml) for the marker.

    Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.

Secondary Outcomes (1)

  • Change in Bone Mineral Density (BMD)

    baseline and 18 months (12 months in 4 subjects)

Study Arms (2)

constant dose

EXPERIMENTAL

Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a constant dose of 30 mcg/day.

Drug: synthetic hPTH 1-34

ascending dose

EXPERIMENTAL

Participants will receive synthetic human parathyroid hormone fragment 1-34 (hPTH 1-34) once-daily in a dose that ascends at 6 month intervals (20-30-40 mcg/day).

Drug: synthetic hPTH 1-34

Interventions

synthetic hPTH 1-34DRUG

Either daily treatment with self-injected hPTH 1-34 or ascending dose treatment at 6-month intervals of hPTH 1-34

Also known as: synthetic human parathyroid hormone 1-34
ascending doseconstant dose

Eligibility Criteria

Age46 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Three or more years after menopause
  • Bone mineral density T-score \< or = -2.0 by dual-energy x-ray absorptiometry (DXA) of vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of vertebral body trabeculae

You may not qualify if:

  • Cannot walk without assistance
  • Significant heart, kidney, liver, or malignant disease
  • Current alcohol abuse
  • Major psychiatric disorders
  • Other current or past disorders known to affect bone
  • Use of medications known to affect bone for \> 7 days in the past 12 months
  • Use of bisphosphonates or fluoride
  • Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests, or complete blood count
  • Elevated calcium levels in 24-hour urine collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Yu EW, Neer RM, Lee H, Wyland JJ, de la Paz AV, Davis MC, Okazaki M, Finkelstein JS. Time-dependent changes in skeletal response to teriparatide: escalating vs. constant dose teriparatide (PTH 1-34) in osteoporotic women. Bone. 2011 Apr 1;48(4):713-9. doi: 10.1016/j.bone.2010.11.012. Epub 2010 Nov 24.

    PMID: 21111078RESULT

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosisBone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Robert Neer, MD
Organization
Massachusetts General Hospital
rneer@partners.org
617-726-6723

Study Officials

  • Robert M. Neer, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Joel S. Finkelstein, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

July 7, 2004

First Posted

July 8, 2004

Study Start

May 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 30, 2013

Results First Posted

September 26, 2013

Record last verified: 2013-09

Locations

US(1)