PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis

2014-08-27 03:58:07 | BioPortfolio


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.


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

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment




PTH, Alendronate


Maine Center for Osteoporosis
United States




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

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:58:07-0400

Clinical Trials [397 Associated Clinical Trials listed on BioPortfolio]

Efficacy of Alendronate Versus Placebo in the Treatment of HIV-Associated Osteoporosis (ANRS120)

Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, i...

Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis

Osteoporosis, a condition in which bones are fragile and break easily, is a major health problem for postmenopausal women. Research studies have shown that both estrogen/progestin replacem...

Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis. II. Assess the safety and efficacy of this treatment...

Continuous Versus Cyclic Treatment With Teriparatide and Alendronate Combined or Teriparatide Alone in Women With Osteoporosis

Osteoporosis is a disease that affects millions of individuals in the United States and abroad. It leads to decreased bone mass and causes an increased risk of fracture. This study will co...

Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis

The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.

PubMed Articles [540 Associated PubMed Articles listed on BioPortfolio]

Comparative Efficacy of Alendronate upon Vertebral Bone Mineral Density and Fracture Rates in East Asians Versus Non-East Asians with Postmenopausal Osteoporosis: A Systematic Review and Meta-Analysis.

Bisphosphonates, such as alendronate, have become the most widely used and effective anti-resorptive therapy for postmenopausal osteoporosis. Previous genetic studies suggest that ethnicity may drive ...

Nebivolol enhances the effect of alendronate against methylprednisolone-induced osteoporosis in rats.

This study aimed to assess the possible modulatory effect of nebivolol against methylprednisolone-induced osteoporosis in rats. Weekly administration of methylprednisolone (7 mg/kg), for six consecu...

Alendronate improves fasting plasma glucose and insulin sensitivity and decreases insulin resistance in prediabetic osteopenic postmenopausal women: a randomized triple-blind clinical trial.

Postmenopausal women receive bisphosphonates for osteoporosis treatment. The effect of these medications on developing diabetes mellitus (DM) in prediabetic patients is yet to be investigated. We aime...

Quality by design approach to optimize the formulation variables influencing the characteristics of biodegradable intramuscular in-situ gel loaded with alendronate sodium for osteoporosis.

There are many challenges facing the use of alendronate sodium for the treatment of osteoporosis such as low bioavailability of 0.6% and oesophageal ulceration with bleeding. Due to the aforementioned...

The role of biphosphonates in the management of thalassemia-induced osteoporosis: a systematic review and meta-analysis.

Thalassemia Major (TM) is a clinical entity with a high prevalence of low bone mass. The aim of the present study was to perform a meta-analysis of all available data on the role of bisphosphonates (B...

Medical and Biotech [MESH] Definitions

A nonhormonal medication for the treatment of postmenopausal osteoporosis in women. This drug builds healthy bone, restoring some of the bone loss as a result of osteoporosis.

Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

The mineral component of bones and teeth; it has been used therapeutically as a prosthetic aid and in the prevention and treatment of osteoporosis.

Breaks in bones resulting from low bone mass and microarchitectural deterioration characteristic of OSTEOPOROSIS.

An aminobisphosphonate derivative of etidronic acid and CALCIUM CHANNEL BLOCKER that inhibits BONE RESORPTION and is used for the treatment of OSTEOPOROSIS.

More From BioPortfolio on "PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis"

Quick Search


Relevant Topics

Diabetes Diabetes Endocrine Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several groups of h...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial