NCT00005005

Brief Summary

This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We will treat the study participants either with PTH and alendronate, alendronate alone, or PTH alone. We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

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

October 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2000

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

8.1 years

First QC Date

March 24, 2000

Last Update Submit

February 4, 2013

Conditions

Osteoporosis

Keywords

PTHAlendronateParathyroid hormoneOsteoporosisPostmenopausal

Outcome Measures

Primary Outcomes (1)

  • Changes in bone mineral density at several sites and changes in biochemical markers

    Year 2

Secondary Outcomes (1)

  • Predictive value of specific biochemical markers of bone turnover

    Year 2

Study Arms (4)

1

EXPERIMENTAL

Participants will receive PTH for 1 year followed by alendronate for 1 year.

Drug: PTHDrug: Alendronate

2

EXPERIMENTAL

Participants will receive PTH and alendronate for 1 year followed by alendronate for 1 year.

Drug: PTHDrug: Alendronate

3

EXPERIMENTAL

Participants will receive alendronate for 2 years.

Drug: Alendronate

4

ACTIVE COMPARATOR

Participants will receive PTH for 1 year followed by placebo for 1 year.

Drug: PTH

Interventions

PTHDRUG
124
AlendronateDRUG
123

Eligibility Criteria

Age55 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 55 and 85 years
  • Postmenopausal (have not had any menses in the last 5 years)
  • Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip and have at least one of the following risk factors for fracture: (a) age \> 65 years; (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal history of hip fracture
  • Willing and able to self-administer daily injections

You may not qualify if:

  • Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years
  • History of more than 12 months of bisphosphonate use ever, or any use (\> 4 weeks) within the past 12 months
  • History of rhPTH (recombinant human PTH) use
  • Any major life-threatening illnesses
  • Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C \> 10.0), or currently using insulin
  • Vitamin D level \< 15 nanograms/ml
  • History of kidney disease (creatinine \> 2.0 mg/dl)
  • Renal insufficiency (creatinine clearance \< 40 mg/min)
  • Any history of kidney stones
  • Any history of hypercalciuria or currently have urine calcium/creatinine \>300 mg
  • History of hypercalcemia, sarcoidosis, or hyperparathyroidism
  • History of active or treated tuberculosis or other granulomatous disorders
  • History of breast cancer, melanoma, or hematologic malignancy that has required treatment within the last 10 years
  • History of bone cancer or any other metabolic bone disease that has required treatment within the last 10 years
  • History of any other nonskin cancer that has required treatment within the last 10 years
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Maine Center for Osteoporosis

Bangor, Maine, 04401, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55415, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JP, Rosen CJ; PaTH Study Investigators. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1207-15. doi: 10.1056/NEJMoa031975. Epub 2003 Sep 20.

    PMID: 14500804RESULT

  • Black DM, Bilezikian JP, Ensrud KE, Greenspan SL, Palermo L, Hue T, Lang TF, McGowan JA, Rosen CJ; PaTH Study Investigators. One year of alendronate after one year of parathyroid hormone (1-84) for osteoporosis. N Engl J Med. 2005 Aug 11;353(6):555-65. doi: 10.1056/NEJMoa050336.

    PMID: 16093464RESULT

  • Bauer DC, Garnero P, Bilezikian JP, Greenspan SL, Ensrud KE, Rosen CJ, Palermo L, Black DM. Short-term changes in bone turnover markers and bone mineral density response to parathyroid hormone in postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2006 Apr;91(4):1370-5. doi: 10.1210/jc.2005-1712. Epub 2006 Jan 31.

    PMID: 16449339RESULT

  • Sellmeyer DE, Black DM, Palermo L, Greenspan S, Ensrud K, Bilezikian J, Rosen CJ. Hetereogeneity in skeletal response to full-length parathyroid hormone in the treatment of osteoporosis. Osteoporos Int. 2007 Jul;18(7):973-9. doi: 10.1007/s00198-007-0336-x. Epub 2007 Feb 28.

    PMID: 17333451RESULT

  • Antoniucci DM, Sellmeyer DE, Bilezikian JP, Palermo L, Ensrud KE, Greenspan SL, Black DM. Elevations in serum and urinary calcium with parathyroid hormone (1-84) with and without alendronate for osteoporosis. J Clin Endocrinol Metab. 2007 Mar;92(3):942-7. doi: 10.1210/jc.2006-1788. Epub 2006 Dec 12.

    PMID: 17164314RESULT

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Dennis Black, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

March 24, 2000

First Posted

March 27, 2000

Study Start

October 1, 1999

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(4)