Tech: Bisphosphonates and risk of dying

[Guest guest]

Hi All, As the subjects states, this is a study of how bisphophonates

respond in terms of what I think is the important for, as for CRON, the

bottom line: staying alive longer. Osteopenia and osteoporosis are a risk

of CR, it has been reported in the literature and among our list members.

Since osteoporosis defined as:

“A disease in which the bones become extremely porous, are subject to

fracture, and heal slowly, occurring especially in women following menopause

and often leading to curvature of the spine from vertebral collapse;

reduction in the amount of bone mass, leading to fractures after minimal

trauma”

is reported to increase the risk of dying, I have been trying to get real

data on the final outcome of therapy. Risedronate is a later

anti-osteoporosis drug that has come on the market. It is reported to have

fewer side-effects, as I had one time apparently. I take it. It should be

a good yardstick to measure the class of drugs generally.

The below report (PDF is available) puts hard numbers on the data. They to

me suggest that these class of drugs are a thumbs-up.

Cheers, Al.

Regul Toxicol Pharmacol 35, June 2002, 320-326

Assessment of Mortality in Patients Enrolled in a Risedronate Clinical Trial

Program: A Retrospective Cohort Study

Steinbucha, Ralph B. D'Agostinob, Jack S. Mandelc,

sond, R.

McClunge, Annette Stemhagenf and Albert Hofmang

“Risedronate, a pyridinyl bisphosphonate, has been shown in large clinical

trials to be effective in the prevention and treatment of osteoporosis.

Analysis of safety data from these trials has shown that risedronate (2.5-

and 5-mg doses) has an overall safety profile comparable to placebo during

the course of the clinical trials. The clinical trials were powered

appropriately to analyze the efficacy endpoints; however, patients were not

systematically followed after completion of the clinical trials and

therefore vital status for most of the patient cohort after the cessation of

the clinical trials was unknown. In order to investigate further the safety

profile of risedronate observed in the clinical trials database, we

conducted a retrospective cohort mortality study among 7981 patients

comprising the intent-to-treat population in three North American

risedronate osteoporosis trials. No difference in all cause mortality was

observed in patients receiving risedronate treatment compared with patients

receiving placebo. There were also no differences between these groups in

mortality due to all cancers, lung cancer, and gastrointestinal tract

cancer. A trend toward lower cardiovascular mortality was observed in the

risedronate groups compared with placebo; this difference was largely due to

a significant reduction in stroke mortality in the active treatment groups.

Follow-up mortality data in this retrospective cohort study demonstrate that

treatment with risedronate has no effect on overall mortality rates.

……………..

DATA for patient mortality relative risk compared to placebo

Patients Placebo 2.5mg 5 mg

Total years follow-up 8558 8462 8558

All-cause 1.00 0.92 0.86

All cancer 1.00 1.12 0.67

GI tract cancer 1.00 0.68 0.42

Cardiovascular 1.00 0.69 0.84

Stroke 1.00 0.36 0.64”

Alan Pater, Ph.D.; Faculty of Medicine; Memorial University; St. 's, NF

A1B 3V6 Canada; Tel. No.: (709) 777-6488; Fax No.: (709) 777-7010; email:

apater@...