PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis

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.

Official Title

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

Conditions

•  Osteoporosis

Study Type

Interventional

Study Design

Treatment, Randomised, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

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

Secondary Outcome Measures:

• Predictive value of specific biochemical markers of bone turnover.

Study Start

October 1999

Eligibility & Criteria

• Ages Eligible for Study: 55 years to 85 years
• Genders 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 oestrogen (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 hypercalciurea or currently have urine calcium/creatinine >300 mg
• History of hypercalcaemia, sarcoidosis, or hyperparathyroidism
• History of active or treated tuberculosis or other granulomatous disorders
• History of breast cancer, melanoma, or haematologic 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 non skin 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

Total Enrolment

236

Contact Details

Maine Center for Osteoporosis    
Bangor, Maine
United States, 04401