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Ipriflavone in the Treatment of Postmenopausal Osteoporosis a Randomized Controlled Trial

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Ipriflavone in the Treatment of Postmenopausal Osteoporosis a Randomized Controlled Trial ORIGINAL CONTRIBUTION Ipriflavone in the Treatment of Postmenopausal Osteoporosis A Randomized Controlled Trial Peter Alexandersen, MD Context Data on the efficacy and safety of ipriflavone for prevention of postmeno- Anne Toussaint, MD pausal bone loss are conflicting. Claus Christiansen, MD, PhD Objectives To investigate the effect of oral ipriflavone on prevention of postmeno- pausal bone loss and to assess the safety profile of long-term treatment with iprifla- Jean-Pierre Devogelaer, MD, PhD vone in postmenopausal osteoporotic women. Christian Roux, MD, PhD Design and Setting Prospective, randomized, double-blind, placebo-controlled, 4-year Jacques Fechtenbaum, MD, PhD study conducted in 4 centers in Belgium, Denmark, and Italy from August 1994 to July 1998. Carlo Gennari, MD, PhD Participants Four hundred seventy-four postmenopausal white women, aged 45 Jean Yves Reginster, MD, PhD to 75 years, with bone mineral densities (BMDs) of less than 0.86 g/cm2. for the Ipriflavone Multicenter Interventions Patients were randomly assigned to receive ipriflavone, 200 mg 3 times European Fracture Study per day (n = 234), or placebo (n = 240); all received 500 mg/d of calcium. TUDIES OF IPRIFLAVONE, A SYN- Main Outcome Measures Efficacy measures included spine, hip, and forearm BMD thetic isoflavone derivative, have and biochemical markers of bone resorption (urinary hydroxyproline corrected for cre- atinine and urinary CrossLaps [Osteometer Biotech, Herlev, Denmark] corrected for suggested that it inhibits bone re- creatinine), assessed every 6 months. Laboratory safety measures and adverse events sorption and stimulates osteo- were recorded every 3 months. Sblast activity in vitro in cell cultures1,2 and Results Based on intent-to-treat analysis, after 36 months of treatment, the annual in vivo in experimental models of osteo- 3 percentage change from baseline in BMD of the lumbar spine for ipriflavone vs pla- porosis. For example, ipriflavone was cebo (0.1% [95% confidence interval {CI}, −7.9% to 8.1%] vs 0.8% [95% CI, 45 demonstrated to inhibit Ca release from −9.1% to 10.7%]; P = .14), or in any of the other sites measured, did not differ sig- fetal long-bone cultures, both spontane- nificantly between groups. The response in biochemical markers was also similar ously and after stimulation with para- between groups (eg, for hydroxyproline corrected for creatinine, 20.13 mg/g [95% thyroid hormone,1 and to inhibit resorp- CI, 18.85-21.41 mg/g] vs 20.67 mg/g [95% CI, 19.41-21.92 mg/g]; P = .96); uri- tion pits induced by osteoclast activity.2 nary CrossLaps corrected for creatinine, 268 mg/mol (95% CI, 249-288 mg/mol) vs Incubation of rat osteosarcoma cells (cell- 268 mg/mol (95% CI, 254-282 mg/mol); P = .81. The number of women with new line UMR 106-a) with ipriflavone re- vertebral fracture was identical or nearly so in the 2 groups at all time points. Lym- phocyte concentrations decreased significantly (500/µL (0.53109/L]) in women sulted in increased release of alkaline treated with ipriflavone. Thirty-one women (13.2%) in the ipriflavone group devel- 4 phosphatase into the media. Further- oped subclinical lymphocytopenia, of whom 29 developed it during ipriflavone treat- more, ipriflavone has been shown to ment. Of these, 15 (52%) of 29 had recovered spontaneously by 1 year and 22 inhibit bone loss in osteoporotic rats (in- (81%) of 29 by 2 years. 3 duced by corticosteroids). These en- Conclusions Our data indicate that ipriflavone does not prevent bone loss or affect couraging results led to a number of clini- biochemical markers of bone metabolism. Additionally, ipriflavone induces lympho- cal trials to test the efficacy on bone mass cytopenia in a significant number of women. in various populations. This inhibition JAMA. 2001;285:1482-1488 www.jama.com of bone loss in these populations was typically mirrored by a reduction in the Author Affiliations are listed at the end of this article. Corresponding Author and Reprints: Peter A complete list of the members of the lpriflavone Mul- Alexandersen, MD, Center for Clinical and Basic Re- concentration of biochemical markers of ticenter European Fracture Study Group was published search, Ballerup Byvej 222, 2750 Ballerup, Denmark bone metabolism.5 In postmenopausal previously (Calcif Tissue Int. 1997;61:528-532). (e-mail: [email protected]). 1482 JAMA, March 21, 2001—Vol 285, No. 11 (Reprinted) ©2001 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/30/2021 IPRIFLAVONE FOR POSTMENOPAUSAL OSTEOPOROSIS women, data on the efficacy of iprifla- medication known to affect bone me- 3 years. An internal quality assurance vone on the prevention of bone loss are tabolism. Women participating in the control was set up at the Danish center conflicting. Nevertheless, most studies study were identified by advertise- for the BMD measurements, as previ- have shown that ipriflavone (typical dos- ments and via the national registration ously described.14 For women who age, 600 mg/d) is able to prevent bone office (Denmark only). dropped out of the study, the last BMD loss,5-9 and some data have even sug- observation was carried forward. gested that ipriflavone may increase bone Ethical Aspects Biochemical Markers of Bone Turn- mass in postmenopausal women.10-13 The study was approved by the local eth- over. Bone formation was determined by However, reports of lymphocytopenia in ics committees and health authorities in serum alkaline phosphatase automatic women taking ipriflavone have gener- all 3 countries recruiting participants to analyzer (Cobas Mira Plus, Roche Diag- ated some concerns regarding the safety the study (Belgium, Denmark, and Italy). nostic Systems, Basel, Switzerland). Bone of ipriflavone.7 The study was conducted in accor- resorption was evaluated by fasting uri- Ipriflavone is marketed and easily dance with the Helsinki Declaration, and nary hydroxyproline corrected by cre- available as an over-the-counter prod- all participants were informed about the atinine by spectrophotometry (UV-160 uct in several countries (ie, Ostovone in study and gave written informed con- A), as described previously.15 In addi- the United States, Osten in Japan, Os- sent before entering the study. tion, bone metabolism was evaluated by teochin in Hungary, and Osteofix and serum calcium, serum phosphorus, and Iprosten in Italy). We report the results Settings urinary excretion of calcium corrected from a large, randomized, double- The study was conducted at 4 Euro- for creatinine (Cobas Mira Plus). In the blind, placebo-controlled, 3-year clini- pean centers. The 2 Belgian centers re- Danish subpopulation, we also mea- cal study,14 designed to investigate the ef- cruited 205 and 52 subjects, the Dan- sured urinary CrossLaps (Osteometer ficacy and safety of ipriflavone on bone ish center recruited 197, and the Italian Biotech A/S, Herlev, Denmark) cor- density, biochemical markers of bone center recruited 20 subjects. Details rected for urinary creatinine as deter- turnover, and fracture rate in postmeno- about the study design have been pub- mined by enzyme-linked immunosor- pausal women with osteoporosis. lished elsewhere.14 bent assay.15 Biochemical markers were assessed at baseline and every 6 months METHODS Study Treatment Groups throughout the study. All analyses were Subjects Women were randomly assigned in performed when the study was com- Four hundred seventy-four white women blocks (assigned to each center) to ei- pleted. between the ages of 45 and 75 years, with ther ipriflavone (200 mg 3 times a day) Incident Nontraumatic Vertebral a natural menopause at least 1 year be- or placebo administered orally in con- Fractures. The incidence of nontrau- fore entering the study, with low bone nection with meals in a double-blind matic vertebral fractures was evaluated mass defined as a bone mineral density fashion. Tablets (ipriflavone or pla- as a secondary end point. Lateral radi- (BMD) of the lumbar spine (L2-L4) be- cebo) were all identical in appearance ography of the thoracic and lumbar spine low 0.86 g/cm2, as determined by the (white, round), smell, taste, and weight. was performed according to a standard- QDR 1000 (Hologic Inc, Waltham, All participants received a concomitant ized acquisition procedure, and as- Mass), corresponding to at least 2 SDs calcium supplementation of 500 mg/d. sessed in a central facility.16 The x-ray below the premenopausal mean value Individual participant treatment code film examination was performed at base- were included in the study. No women envelopes were provided to the investi- line (unless this had been done less than with a body mass index lower than 30 gator by the sponsor prior to allocation. a year prior to entry in the study) and kg/m2 were enrolled. Protocol exclu- The lead investigator kept the treat- again after years 1, 2, and 3. The x-ray sion criteria were (1) any x-ray film that ment code envelopes in a locked, secure films were evaluated by a radiologist documented previous vertebral frac- storage facility. Unblinding of the indi- blinded to treatment. A fracture was de- ture, substantial scoliosis, osteophyto- vidual treatment codes occurred upon fined as a 20% or greater reduction of the sis, or spinal secondary osteoporosis, or completion of the study by all subjects. anterior, middle, or posterior height of bone-related diseases; (2) significant con- a vertebra at the level of T4-L4.16 The to- comitant disease or medical history that End Points tal number of incident spinal fractures could interfere with the study; (3) alco- Bone Mineral Density. Lumbar spine and the number of women with inci- hol abuse; (4) medication such as sex ste- (L2-L4), total hip, and distal radius BMD dent fractures were then calculated for roids, bisphosphonates, calcitonin, fluo- was determined by dual-energy radio- each group.14 ride, glucocorticoids within 12 months graph absorptiometry (QDR 1000).
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