PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis

Sponsor

Dennis Black (Other)

Overall Status

Completed

CT.gov ID

NCT00005005

Collaborator

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

238

Enrollment

Locations

Arms

Duration (Months)

59.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: PTH Drug: Alendronate	Phase 2

Detailed Description

The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women.

238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers.

In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus.

Study Design

Study Type:

Interventional

Actual Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis

Study Start Date :

Oct 1, 1999

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Participants will receive PTH for 1 year followed by alendronate for 1 year.	Drug: PTH Drug: Alendronate
Experimental: 2 Participants will receive PTH and alendronate for 1 year followed by alendronate for 1 year.	Drug: PTH Drug: Alendronate
Experimental: 3 Participants will receive alendronate for 2 years.	Drug: Alendronate
Active Comparator: 4 Participants will receive PTH for 1 year followed by placebo for 1 year.	Drug: PTH

Outcome Measures

Primary Outcome Measures

Changes in bone mineral density at several sites and changes in biochemical markers [Year 2]

Secondary Outcome Measures

Predictive value of specific biochemical markers of bone turnover [Year 2]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
History of symptomatic esophageal reflux, achalasia or esophageal stricture
Currently taking > 7.5 mg systemic prednisone or equivalent per day
Currently using > two puffs, four times/day of inhaled steroids
Currently taking anticoagulants or anticonvulsants
Have used Calcitonin within the past 3 months
Have used Raloxifene in the last 6 months or for more than 12 months in the last 2 years
Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2 years
Have used fluoride for at least a month within the past 5 years
Currently taking > 1000 IU/day vitamin D or vitamin D analogues or metabolites
Currently taking thyroid hormone replacement AND have a TSH < 0.1mIU/L

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maine Center for Osteoporosis	Bangor	Maine	United States	04401
2	University of Minnesota	Minneapolis	Minnesota	United States	55415
3	Columbia University	New York	New York	United States	10032
4	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213