NCT00000400

Brief Summary

This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 1999

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

August 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

6.7 years

First QC Date

November 3, 1999

Last Update Submit

December 6, 2013

Conditions

Osteoporosis

Keywords

OsteoporosisBone formationBone resorptionParathyroid hormone (PTH)Postmenopause

Outcome Measures

Primary Outcomes (1)

  • change in spine bone mineral density

    study months 30 (phase A), 42 (phase B), 54 (phase C)

Secondary Outcomes (10)

  • change in hip bone mineral density

    study months 30 (phase A), 42 (phase B), 54 (phase C)

  • change in forearm bone mineral density

    study months 30 (phase A), 42 (phase B), 54 (phase C)

  • change in total body bone mineral

    study months 30 (phase A), 42 (phase B), 54 (phase C)

  • change in femoral shaft bone mineral density

    study months 30 (phase A), 42 (phase B), 54 (phase C)

  • change in serum PINP

    study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)

  • +5 more secondary outcomes

Study Arms (3)

PTH

EXPERIMENTAL

Human parathyroid hormone \[hPTH-(1-34)\]

Drug: Human parathyroid hormone [hPTH-(1-34)]

ALN

ACTIVE COMPARATOR

Alendronate

Drug: alendronate

PTH+ALN

EXPERIMENTAL

Human parathyroid hormone \[hPTH-(1-34)\] plus alendronate

Drug: Human parathyroid hormone [hPTH-(1-34)]Drug: alendronate

Interventions

Human parathyroid hormone [hPTH-(1-34)]DRUG

37 mcg once daily by self-administered sc injection

Also known as: teriparatide
PTHPTH+ALN
alendronateDRUG

70 mg/week by oral route

Also known as: Fosamax
ALNPTH+ALN

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lumbar spine or hip BMD T-score less than or equal to minus 2.0
  • Postmenopausal at least 5 years
  • Fully ambulatory
  • Able to give informed consent

You may not qualify if:

  • No concurrent illnesses that cause bone loss
  • No recent drug treatment for osteoporosis
  • No recent fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Finkelstein JS, Wyland JJ, Leder BZ, Burnett-Bowie SM, Lee H, Juppner H, Neer RM. Effects of teriparatide retreatment in osteoporotic men and women. J Clin Endocrinol Metab. 2009 Jul;94(7):2495-501. doi: 10.1210/jc.2009-0154. Epub 2009 Apr 28.

    PMID: 19401368DERIVED

Related Links

MeSH Terms

Conditions

OsteoporosisBone Resorption

Interventions

PTH protein, humanTeriparatideAlendronate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Robert M. Neer, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

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
Physician

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1999

Primary Completion

April 1, 2006

Study Completion

June 1, 2006

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations

US(1)