Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women.

CONTEXT: Treatment of osteoporosis with an anabolic agent, teriparatide [human PTH 1-34 (TPTD)], is effective in reducing incident fractures, but patient resistance to daily sc injections has limited its use. A novel transdermal patch, providing a rapid, pulse delivery of TPTD, may provide a desirable alternative. OBJECTIVE: The aim of the study was to determine the safety and efficacy of a novel transdermal TPTD patch compared to placebo patch and sc TPTD 20-microg injection in postmenopausal women with osteoporosis. DESIGN: Our study consisted of 6-month, randomized, placebo-controlled, positive control, multidose daily administration. PATIENTS: We enrolled 165 postmenopausal women (mean age, 64 yr) with osteoporosis. INTERVENTIONS: A TPTD patch with a 20-, 30-, or 40-microg dose or a placebo patch was self-administered daily for 30-min wear time, or 20 microg of TPTD was injected daily. OUTCOMES: The primary efficacy measure was mean percentage change in lumbar spine bone mineral density (BMD) from baseline at 6 months. RESULTS: TPTD delivered by transdermal patch significantly increased lumbar spine BMD vs. placebo patch in a dose-dependent manner at 6 months (P < 0.001). TPTD 40-microg patch increased total hip BMD compared to both placebo patch and TPTD injection (P < 0.05). Bone turnover markers (procollagen type I N-terminal propeptide and C-terminal cross-linked telopeptide of type I collagen) increased from baseline in a dose-dependent manner in all treatment groups and were all significantly different from placebo patch (P < 0.001). All treatments were well tolerated, and no prolonged hypercalcemia was observed. CONCLUSION: Transdermal patch delivery of TPTD in postmenopausal women with osteoporosis for 6 months is safe and effective in increasing lumbar spine and total hip BMD.

Non-medical use of OxyContin Tablets in the United States.

The non-medical use of OxyContin (controlled release oxycodone HCl) Tablets has been widely cited in media reports often leaving the impression that OxyContin was a source of primary or new onset drug abuse. However, no published research to date has examined the drug use history of those reporting non-medical use of OxyContin. This study examined rates of non-medical OxyContin use in the United States and the demographic and drug use profiles of those reporting such use, based on data from the 1999, 2000, and 2001 Substance Abuse and Mental Health Services Administration National Household Survey on Drug Abuse. Reported lifetime non-medical OxyContin use in the United States increased from 0.1% to 0.2% to 0.4% in 1999, 2000, and 2001 suggesting new incidence of 0.1%-0.2% per year. Compared to those reporting non-medical use of prescription analgesics other than OxyContin, non-medical OxyContin users were more likely to show a pattern of more serious drug abuse: they used multiple drugs, used needles for drug injection, and had higher rates of abuse and dependence. Approximately 83% of non-medical OxyContin users reported having used illicit drugs or other prescription medications non-medically prior to their first non-medical use of prescription analgesics. Even compared to those who reported non-medical use of other prescription analgesics, non-medical OxyContin users already had a more significant pattern of drug abuse before they began using prescription analgesics for non-medical purposes, suggesting that non-medical use of OxyContin is rarely the initiating factor leading to the abuse of other drugs.

Cost and cost-effectiveness of standard methadone maintenance treatment compared to enriched 180-day methadone detoxification.

AIMS: To compare the cost and cost-effectiveness of methadone maintenance treatment and 180-day methadone detoxification enriched with psychosocial services. DESIGN: Randomized controlled study conducted from May 1995 to April 1999. SETTING: Research clinic in an established drug treatment program. PARTICIPANTS: One hundred and seventy-nine adults with diagnosed opioid dependence. Intervention Patients were randomized to methadone maintenance (n = 91), which required monthly 1 hour/week of psychosocial therapy during the first 6 months or 180-day detoxification (n = 88), which required 3 hours/week of psychosocial therapy and 14 education sessions during the first 6 months. MEASUREMENTS: Total health-care costs and self-reported injection drug use. A two-state Markov model was used to estimate quality-adjusted years of survival. Findings Methadone maintenance produced significantly greater reductions in illicit opioid use than 180-day detoxification during the last 6 months of treatment. Total health-care costs were greater for maintenance than detoxification treatment ($7564 versus $6687; P < 0.001). Although study costs were significantly higher for methadone maintenance than detoxification patients ($4739 versus $2855, P < 0.001), detoxification patients incurred significantly higher costs for substance abuse and mental health care received outside the study. Methadone maintenance may provide a modest survival advantage compared with detoxification. The cost per life-year gained is $16 967. Sensitivity analysis revealed a cost-effectiveness ratio of less than $20 000 per quality-adjusted life-year over a wide range of modeling assumptions. CONCLUSIONS: Compared with enriched detoxification services, methadone maintenance is more effective than enriched detoxification services with a cost-effectiveness ratio within the range of many accepted medical interventions and may provide a survival advantage. Results provide additional support for the use of sustained methadone therapy as opposed to detoxification for treating opioid addiction.