Zometa Works - Study

a.. Medical News from
ASCO GU: American Society of Clinical Oncology-Genitourinary Cancer
Symposium Meeting

ASCO GU: Bisphosphonate Effective Long Term in Prostate Cancer Hormone
Therapy
By Crystal Phend, Staff Writer, MedPage Today
Published: February 18, 2008
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.



SAN FRANCISCO, Feb. 18 -- Zoledronic acid (Zometa) improves bone mineral
density in long-term use during androgen suppression therapy for prostate
cancer, researchers found.

Zoledronic acid significantly increased T scores in both hips and the lumbar
spine (P<0.05) over more than a year of use in older high-risk men,
according to a small randomized trial presented here at the American Society
of Clinical Oncology Genitourinary Cancers Symposium.

This was true even when the drug was started later in the course of therapy,
reported William R. Broderick, M.D., of Loyola University Medical Center in
Maywood, Ill., and colleagues.

Starting zoledronic acid later may allow men to avoid the drug's side
effects of bone pain and renal impairment until bone mineral density changes
appear, Dr. Broderick said.


Men who are at lower risk based on comorbidities and annual screening
of bone mineral density may be able to first pursue lifestyle modification,
including exercise and smoking cessation, said Nirmala Bhoopalam, M.D., of
Loyola and the Edward Hines Jr. VA Hospital in Hines, Ill., who was a
co-author.


Longer-term use among men on androgen deprivation therapy has not been
studied; nor was there proof it would prevent bone loss if not started at
the same time as hormone therapy, the researchers noted.


So, they randomized 93 men with nonmetastatic prostate cancer treated
at VA medical centers to receive a double blind intravenous infusion every
three months of 4 mg zoledronic acid or placebo.


Men in both groups were also started on calcium, vitamin D, and
weight-bearing exercise.


Mean age was 70.5 years; 55% were Caucasian, 41% African-American, and
4% Hispanic, and mean BMI was 29.4.


None of the men had osteoporosis at baseline, defined as a bone
mineral density (BMD) T score of -2.0 or less as measured by dual energy
X-ray absorptiometry. Follow-up scans were done at six and 12 months.


Overall, T-score percent change was significantly better with active
treatment than placebo for the left and right hip (both P<0.05) and most
dramatically so for the lumbar spine (6% increase versus more than 1%
decrease, P<0.05).


Among the 50 patients who had been on androgen deprivation therapy for
less than a year at baseline, bone mineral density increased 5.95% with
zoledronic acid but decreased 3.23% with placebo (P=0.0044).


Among the 43 patients who started in the study more than a year after
initiation of hormone therapy, bone mineral density increases were greater
with zoledronic acid (6.08% versus 1.57%, P=0.0005).


Bone mineral density in left and right hips also increased in both
groups with active treatment (P<0.05), which is important, Dr. Bhoopalam
said, because hip fractures are the type most worrisome to patients.


Although the study was not of long enough duration to see an impact on
fracture incidence, Dr. Bhoopalam said it's safe to assume that an increase
in bone mineral density would be associated with reduced fracture risk.


The study was supported by a grant from Novartis. The
researchers reported no conflicts of interest.



Primary source: ASCO GU meeting
Source reference:
Broderick WR, et al "A phase III trial of zoledronic acid (Z) to
prevent osteoporosis in men on early and prolonged androgen deprivation
therapy (ADT) in a high risk VA population" ASCO GU meeting 2008; Abstract
177.


--
PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3cN0M0 Neg margins
PSA <.1 <.1 <.1 .27 .37 .75 PSAD 0.19 years
EBRT 05-07/2002 @ 47
PSA .34 .22 .15 .21 .32 PSAD .056 years
Lupron 07/03 (1 mo) 8/03 and every 4 months there after
PSA .07 .05 .06 .09 .08 .132 .145 PSAD 1.4 years
Casodex added daily 07/06
PSA undetectable since, < 0.04 on 10/09/08
Illegitimati non carborundum

Steve Kramer wrote:

Among the 50 patients who had been on androgen deprivation therapy for
less than a year at baseline, bone mineral density increased 5.95% with
zoledronic acid but decreased 3.23% with placebo (P=0.0044).

Among the 43 patients who started in the study more than a year
after initiation of hormone therapy, bone mineral density increases
were greater with zoledronic acid (6.08% versus 1.57%, P=0.0005).

----------------

Isn't it sad, to be a guinea pig for tests and than you're chosen to receive
the placebo?

Frans wrote:
> Steve Kramer wrote:
>
> Among the 50 patients who had been on androgen deprivation therapy for
> less than a year at baseline, bone mineral density increased 5.95% with
> zoledronic acid but decreased 3.23% with placebo (P=0.0044).
>
> Among the 43 patients who started in the study more than a year
> after initiation of hormone therapy, bone mineral density increases
> were greater with zoledronic acid (6.08% versus 1.57%, P=0.0005).
>
> ----------------
>
> Isn't it sad, to be a guinea pig for tests and than you're chosen to receive
> the placebo?
>
>
Considering how many studies reveal more harm than good, that's not
always a bad thing.

I.P.

"Frans" <im@fromholland.invalid> wrote in message
news:740b6$49ad62fd$5354a0e2$30445@cache120.multik abel.net...

> Isn't it sad, to be a guinea pig for tests and than you're chosen to
> receive the placebo?

Two cops are chasing an killer with multiple victims to his credit. The
robber turns into an entryway and the cops follow. When they get to the
entry, they find the entry is for two buildings and between the two is an 8
foot privacy fence. The fence continues long past the back of the
buildings. The cops know if they stop, they'll lose the killer will get
away and kill again. One picks one side and the other chooses the other
side. Both know that they chance of getting shot are 50/50. They do it
anyway.

I do not find the man involved in a double-blind study to be any less brave.

--
PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3cN0M0 Neg margins
PSA <.1 <.1 <.1 .27 .37 .75 PSAD 0.19 years
EBRT 05-07/2002 @ 47
PSA .34 .22 .15 .21 .32 PSAD .056 years
Lupron 07/03 (1 mo) 8/03 and every 4 months there after
PSA .07 .05 .06 .09 .08 .132 .145 PSAD 1.4 years
Casodex added daily 07/06
PSA undetectable since, < 0.04 on 10/09/08
Illegitimati non carborundum

On March 3, Steve K wrote:

(snip)

> I do not find the man involved in a double-blind study to be any less brave.

I second that.

And let us honor those brave and selfless men who comprised the study
cohort in the trial of docetaxel (Taxotere).

They were far advanced and knew that, as my med onc puts is, they were
"on their last legs," and had no hope. They volunteered for you and me,
not for themselves. And they succeeded.

I will always honor those heroes.

On Zometa: it is also known to impede progress of bone mets.

See, Berenson JR, et al., "Treatment strategies for skeletal
complications of cancer." Cancer Biol Ther. 2006 Sep;5(9):1074-7.

PubMed ID 16969118

Pub Med, a service of the US National Library of Medicine, at www.pubmed.gov

The small but important risk of osteonecrosis of the jaw is easily avoided.

Regards,

Steve J