Selected ongoing clinical trials #. (Featured CME Topic: Osteoporosis).

* BONE LOSS IN PREMENOPAUSAL WOMEN WITH DEPRESSION

This 12-month interventional, randomized study is designed to determine whether alendronate (Fosamax) can increase or maintain bone mass in osteoporotic women with major depression. Elevated stress hormone levels may contribute to bone loss. This study will also determine whether women with major depression, aged 21 to 45 years, lose bone mass at a faster rate than healthy women. Women who have a current or a past history of bipolar, schizophrenia, or eating disorders or who are known to have a risk for suicide are not eligible. Other drug/health related eligibility criteria apply.

Contact: Patient Recruitment and Public Liaison Office, National Institute of Mental Health (NIMH), 9000 Rockville Pike, Bethesda, MD 20892. [phone].

* OSTEOPOROSIS IN CHILDREN AND ADULTS FOLLOWING LIVER TRANSPLANTATION

The aim of this observational, pilot project is to identify the prevalence of adults with osteoporosis who have undergone liver transplantation as a child, and to evaluate this group for osteoporosis risk factors. Chronic liver disease adversely affects bone metabolism in children; therefore, outcomes of bone density cannot be predicted after the growth period on adults who were transplant recipients. Participants must be 16 to 40 years of age who have undergone liver transplantation as a child or young adult.

Contact: Khalid Khan, MBChB, University of Minnesota, Minneapolis, MN 55455. [phone].

* RANDOMIZED STUDY OF HUMAN PARATHYROID HORMONE IN MIDDLE-AGED MEN WITH IDIOPATHIC OSTEOPOROSIS

The objective of this randomized, double-blind, placebo-controlled study is to determine the efficacy of parathyroid hormone (PTH 1-34) on bone mass in middle-aged men diagnosed with idiopathic osteoporosis. Participants will self-administer daily injections of PTH 1-34 or a placebo for 2.5 years. Subjects will be monitored for adverse toxicities. Male adults aged 29 to 67 years with no family history of male osteoporosis or metabolic bone diseases are eligible. Other exclusions include: no concurrent glucocorticoid therapy, prior steroid use, prior gastrointestinal tract surgery, alcoholism, diabetes mellitus, hypercortisolism, and no concurrent anti-seizure medication. Eligibility status includes other drug/health related criteria.

Contact: John Paul Bilezikian, Columbia University College of Physicians and Surgeons, New York, NY 10032. [phone].

* RANDOMIZED STUDY OF ALENDRONATE IN ADULT PATIENTS WITH CYSTIC FIBROSIS-RELATED OSTEOPOROSIS

In this randomized, double-blind study, researchers seek to determine the biologic effect and the bioavailability of alendronate on bone metabolism in participants with cystic fibrosis-related osteoporosis. This study will also determine the safety and efficacy of alendronate therapy on this group. Group 1 will be administered vitamin D, calcium and an alendronate placebo daily for 1 month; group 2 will receive vitamin D, calcium and oral alendronate daily for 1 month. Treatment will continue if bone mineral density varies between the groups. Patients aged 18 to 45 years are eligible. Male and female participants are stratified according to osteoporosis disease severity and sex (male vs female). Participants must be ambulatory and have received endocrine therapy within the past 3 months, and before corticosteroid treatments. Exclusions: no history of esophagitis, creatinine [less than or equal to]3 mg/dL, and no renal failure. This study is currently recruiting participants. Other health/drug related criteria apply.

Contact: Robert Aris, University of North Carolina School of Medicine, Chapel Hill, NC 27599-7070. [phone].

* PARATHYROID HORMONE (PTH) WITH ALENDRONATE FOR OSTEOPOROSIS

The object of this 21-month, randomized, open label, placebo-controlled study is to test the combined efficacy of parathyroid hormone (PTH) and alendronate to increase bone mass in females [greater than or equal to]50 years of age. Researchers will investigate the bone metabolism outcomes of postmenopausal women from 2 different treatment groups and compare them with a control (alendronate alone) group. The two treatment groups will be randomized to receive either PTH daily with alendronate or PTH in a cyclical fashion administered 3 out of 6 months along with daily alendronate. The study is now in phase II and currently recruiting patients. Eligibility requirements include but are not limited to: hip and lumbar spine T-score at time of recruitment must be [less than or equal to]2.5, and subjects must not be on any other medications known to influence bone metabolism except alendronate. Participants also must have primary osteoporosis.

Contact: Robert Lindsay, MD, Helen Hayes Hospital Clinical Research Center, West Haverstraw, NY 10993. [phone].

* PATHOPHYSIOLOGY OF PTH-RELATED PROTEIN IN HUMANS

The purpose of this randomized, doubleblind, placebo-controlled study is to determine the effects of human hormone PTHrP on bone mass in postmenopausal women. PTHrP is closely related to another hormone, parathyroid hormone (PTH), and PTH is a proven and effective treatment for osteoporosis in both humans and animals. Recent studies indicate that PTHrP is effective in treating osteoporosis in laboratory animals and therefore may be effective in humans as well. This is the first human trial of PTHrP. Healthy women aged 50 to 75 years with a low bone mineral density at the hip and lumbar spine are eligible. Exclusion criteria include females with any known heart, liver, kidney, lung, hormonal, or musculoskeletal diseases (except osteoporosis). Other exclusions apply.

Contact: Marybeth Tedesco, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213. [phone]. E-mail: [e-mail].

* CAN PARATHYROID HORMONE INJECTIONS REVERSE GLUCOCORTICOIDINDUCED OSTEOPOROSIS

The main focus of this 4-year study is to determine whether or not parathyroid hormone (PTH 1-34) both increases and maintains bone mass in postmenopausal women currently taking glucocorticoids (prednisone [greater than or equal to]5 mg/day). Long-term use of steroids results in severe bone loss, which often leads to osteoporotic fractures. Study participants will be assigned to one of two groups. Group 1 will receive PTH 1-34 injections daily for 2 years; group 2 will receive a placebo for 2 years. Researchers will determine whether PTH 1-34 will increase bone mass and determine what type of anti-resorptive treatment will best maintain the newly formed bone. All subjects must currently take estrogen-progesterone or raloxifene. Other drug/health eligibility criterion may apply.

Contact: Nancy E. Lane, MD, San Francisco General Hospital, San Francisco, CA 94110. [phone]. E-mail: [e-mail].

* DETERMINING THE RISK FACTORS SUCH AS SMOKING, ALCOHOL, AND CAFFEINE AND THEIR ASSOCIATION WITH OSTEOPOROSIS IN MEN

Rates of baseline bone mineral density (BMD) loss and the associations between potential risk factors such as smoking, alcohol, and caffeine for osteoporosis among male veterans are the main objectives of this observational 2-year study. BMD will be ascertained from the hip, forearm, and total body. A questionnaire will determine current tobacco use, alcohol use, physical activity, and diet. This study is one of the largest studies conducted on the risk factors for osteoporosis in men in the U.S. One thousand male veteran recruits aged [greater than or equal to]50 years will be drawn from two existing VA cohorts: the Normative Aging Study and the Veterans Health Study.

Contact: Donald Miller, ScD, Boston VA Health Care System, Jamaica Plain, MA 02130. [phone].

* OSTEOPOROSIS PREVENTION AFTER HEART TRANSPLANT

The efficacy and safety of alendronate and calcitriol on bone mass in heart transplant recipients are the focal points of this randomized, double-blind, 12-month study. Rapid bone loss in the spine and hips is a complication of heart transplantation. Low bone mass is associated with fractures, and approximately 35% of heart transplant recipients will suffer broken bones during the first year post-operatively. Subjects will be divided into two groups and administered either alendronate and a calcitriol placebo, or calcitriol and alendronate placebo within 1 month of transplantation. Eligible subjects must be 20 to 70 years of age and have had a cardiac transplantation. Other drug/health eligibility requirements apply.

Contact: Vicki Addesso-Dodd, New York-Presbyterian Hospital, Columbia Campus, New York, NY 10032. [phone]. E-mail: [e-mail].

* PATH STUDY: PARATHYROID HORMONE AND ALENDRONATE FOR OSTEOPOROSIS

The objective of this two-year randomized, multicenter, double-blind, placebo-controlled study is to test the efficacy of human parathyroid hormone (PTH 1-34) combined with alendronate in the treatment of osteoporosis in postmenopausal women aged 55 to 85 years (n = 240). Measurements of biochemical markers will be assessed to determine whether bone marker turnover is an effective predictor of the skeletal response to combination therapy. Eligible subjects must have a spine, femoral neck or a total hip T-score [less than or equal to]-2.0, and have at least one of the following risk factors: history of postmenopausal fracture, age >65 years, or maternal history of hip fracture. Other eligibility determinants may apply.

Contact: Trisha Hue, Maine Center for Osteoporosis, Bangor, ME 04401; University of Minnesota, Minneapolis, MN 55415; Columbia University, New York, NY 10032; or University of Pittsburgh Medical Center, Pittsburgh, PA 15213. [phone]. E-mail: [e-mail].

* TREATMENT OF CHILDHOOD OSTEOPOROSIS WITH ALENDRONATE (FOSAMAX)

Testing the efficacy of alendronate on bone mineral density in children aged 6 to 17 years old who have glucocorticoid-induced or idiopathic juvenile osteoporosis is the aim of this study. Osteoporosis is a rare but serious disease in children. Its effects can last through adulthood and cause pain, broken bones, even fractures of the spine along the way. Osteoporosis occurs when bone is resorbed faster than it is formed. The drug alendronate stops bone resorption and thereby assists in bone metabolism. The central aim of this study is to determine the efficacy of alendronate in children with osteoporosis. Several eligibility and exclusion requirements apply: patients with prior treatment with bisphosphonates will be excluded, and patients must not be pregnant.

Contact: Patient Recruitment, National Institute of Child Health and Human Development (NICHD), 9000 Rockville Pike, Bethesda, MD 20892. [phone].

# Prepared by Dianne Rose.