Alendronate and/or Parathyroid Hormone for Osteoporosis | NCT00000400

Studies
Alendronate and/or Parathyroid Hormone for Osteoporosis

NCT00000400

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Dec 9, 2013Estimated

Enrollment

176Actual

Phase

Phase 2

Conditions

Osteoporosis

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50AR044855	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1999

Primary Completion Date

Apr 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Nov 3, 1999

First Posted Date

Nov 4, 1999Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2013

Last Update Posted Date

Dec 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert M. Neer, MD, Physician, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).

Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.

Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.

During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

176Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Human parathyroid hormone [hPTH-(1-34)]	Drug	37 mcg once daily by self-administered sc injection	PTH PTH+ALN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in spine bone mineral density		study months 30 (phase A), 42 (phase B), 54 (phase C)

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert M. Neer, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19401368	Derived	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.

ID	Term
D010024	Osteoporosis
D001862	Bone Resorption

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

ID	Term
C470125	PTH protein, human
D019379	Teriparatide
D019386	Alendronate

ID	Term
D010281	Parathyroid Hormone
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists