Prevention of early postmenopausal bone loss by risedronate: One year follow-up data

Mortensen, Lene; Bekker, Pirow; Digennaro, Joseph; Axelrod, Douglas W.; Charles, Peder; Johnston, Christine A.

doi:10.1016/8756-3282(96)87981-6

Cited by 7 publications

(7 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In contrast with our statistical analysis, they compared the rate of bone loss in the placebo group during the initial 3 years with the rate of bone loss in the former alendronate group over 3 posttreatment years and concluded that bone loss resumes at a normal rate after cessation of treatment. Similarly, Mortensen et al [13] reported that 1 year after withdrawal of 5 mg/day risedronate for 2 years in early postmenopausal women there was a significant decrease in BMD and prompt increase in biochemical markers. Ravn et al [22] reported that the rate of BMD decrease and levels of biochemical markers of bone turnover returned to normal after discontinuation of ibandronate in women at least 10 years postmenopausal with low radial BMD.…”

Section: Discussionmentioning

confidence: 91%

“…There is limited information on how long these compounds are retained in the skeleton, with a large variation in the reported terminal half-life ranging from 12.8 hours for clodronate [6] to greater than 10 years for alendronate [7]. Although not much is known on the pharmacological activity of BPs remaining in the body, clinical studies have shown persistent efficacy after dosing is terminated [8][9][10][11].Recent studies have provided evidence for a beneficial role of BPs in primary prevention of postmenopausal bone loss [12][13][14]. Administration of cyclical etidronate for a 2-year duration has been shown to prevent bone loss in women within 10 years of menopause [14][15][16][17][18].…”

mentioning

confidence: 98%

“…Recent studies have provided evidence for a beneficial role of BPs in primary prevention of postmenopausal bone loss [12][13][14]. Administration of cyclical etidronate for a 2-year duration has been shown to prevent bone loss in women within 10 years of menopause [14][15][16][17][18].…”

mentioning

confidence: 99%

See 2 more Smart Citations

Cyclical Etidronate Therapy for Prevention of Postmenopausal Bone Loss: A 1-Year Open-Label Follow-Up Study

et al. 2000

View full text Add to dashboard Cite

The objective of this study was to evaluate whether the pharmacological activity of cyclical etidronate therapy is sustained beyond the dosing period. A group of 121 postmenopausal women who had completed a 2-year, double-blind, placebo-controlled parallel study with etidronate or placebo (400 mg/day for 14 days every 3 months) and calcium agreed to participate in a 1-year open-label follow-up study to evaluate the effect of discontinuing etidronate treatment. Fifty-nine subjects in the former etidronate group and 62 in the placebo group received 500 mg/day of elemental calcium; 54/59 and 58/62 subjects, respectively, completed the study. Outcomes of the study were bone mineral density (BMD), measured by dual energy X-ray absorptiometry (DXA), and biochemical markers of bone turnover (urinary deoxypyridinoline/creatinine and serum osteocalcin). To determine whether there was a residual effect of previous therapy we compared mean percentage changes from baseline (year 0) to year 3 for both spinal and femoral neck BMD and markers of bone turnover in the former cyclical etidronate and placebo groups. To evaluate the carryover effect of treatment we compared the percent change from year 2 to year 3 for the same variables. Mean percentage change (SEM) from year 2 to year 3 for spinal BMD in the former cyclical etidronate group was -2.87% (0.48%) versus -0.99% (0.36%) in the placebo group (P = 0.0022). In the femoral neck, the BMD changes were -0.86% (0.42%) versus -1.01% (0.41%) (NS). Biochemical markers increased within 6 months toward baseline levels. Mean percentage changes from baseline (year 0) in both spinal and femoral neck BMD were significantly different between groups 1 year after treatment discontinuation. No differences between groups were maintained in deoxypyridinoline and osteocalcin. It is concluded that following withdrawal of cyclical etidronate therapy bone loss resumes at a normal and moderately accelerated rate in the proximal femur and lumbar spine, respectively. A positive effect on BMD at both cortical and trabecular sites is maintained for 1 year after treatment withdrawal.

show abstract

Section: Discussionmentioning

confidence: 91%

mentioning

confidence: 98%

See 1 more Smart Citation

Cyclical Etidronate Therapy for Prevention of Postmenopausal Bone Loss: A 1-Year Open-Label Follow-Up Study

et al. 2000

View full text Add to dashboard Cite

show abstract

“…Recent studies have suggested that dosing prior to breakfast might be better. Furthermore, preliminary data from ongoing studies have shown a positive effect on bone mass in early postmenopausal women treated with 5 mg continuous risedronate [47], and in late postmenopausal women with low bone mass treated with 5 mg continuous or 20 mg cyclic risedronate [26,44].…”

Section: Discussionmentioning

confidence: 99%

A 2-Year Phase II Study with 1-Year of Follow-up of Risedronate (NE-58095) in Postmenopausal Osteoporosis

et al. 1997

View full text Add to dashboard Cite

This paper presents the results of a two-center, double-masked, placebo-controlled, randomized, oral-dose study of risedronate treatment in postmenopausal osteoporosis. Patients had at least one, but no more than four prevalent vertebral fractures at baseline. They received either 2.5 mg continuous risedronate, 2.5 mg cyclic risedronate, or placebo for 2 years. Both risedronate and placebo were formulated as hard gelatin capsules. All women furthermore received a daily calcium supplement of 1 g which was taken separately from the study drug. During the 1-year of follow-up, all women received only a daily calcium supplement of 1 g. A total of 132 patients were enrolled (44 in each treatment group), of which 73% completed the 2-year treatment period and 70% all 3 years. Generally the outcome of the study was negative. Lumbar spine bone mineral density (BMD) increased 1.2% (NS) and 0.8% (NS) and after 2 and 3 years in the group treated with continuous risedronate, 1.7% (NS) and 2.3% (p < 0.05) in the group treated with cyclic risedronate, and 0.6% (NS) and 1.7% (NS) in the placebo group. BMD in the femoral neck increased 2.9% (p < 0.05) and 0.9% (NS) after 2 and 3 years in the group treated with continuous risedronate, 1.3% (NS) and 2.4% (p < 0.01) in the group treated with cyclic risedronate, and 1.3% (NS) and 2.6% (p < 0.01) in the placebo group. The differences between all three groups in spinal and femoral BMD after 2 years were not statistically significant, but reached statistical significance after 3 years (p < 0.01) in the femoral neck. Only minor changes were observed in the measured markers of bone turnover. Both the incidence and rate of new vertebral fractures showed no overall differences between the groups. The distribution of adverse events was similar across treatment groups. None of the serious adverse events were considered causally related to risedronate. The lack of effect shown in the present study may be explained by insufficient dose regimen and/or impaired absorption from the intestinal tract. Further investigations (ongoing phase III trials) are needed to define future dose regimens in order to validate the effect on bone mass, fracture rate and biochemical markers. In these studies another formulation of the drug and other dosing instructions are used.

show abstract

“…Prevention of early postmenopausal bone loss has been successfully achieved by the use of drugs specifically aimed at reducing or inhibiting bone resorption. Estrogen [3], calcitonins [4,5] and bisphosphonates [6][7][8] are now considered safe and effective ways of maintaining mineral density of trabecular and/or cortical bone at premenopausal levels by counteracting the exacerbated activity of osteoclasts induced by the sharp postmenopausal decrease in circulating endogenous estrogens.…”

mentioning

confidence: 99%

Parathyroid hormone in the treatment of involutional osteoporosis: Back to the future

et al. 1997

View full text Add to dashboard Cite

Prevention of early postmenopausal bone loss by risedronate: One year follow-up data

Cited by 7 publications

References 0 publications

Cyclical Etidronate Therapy for Prevention of Postmenopausal Bone Loss: A 1-Year Open-Label Follow-Up Study

Cyclical Etidronate Therapy for Prevention of Postmenopausal Bone Loss: A 1-Year Open-Label Follow-Up Study

A 2-Year Phase II Study with 1-Year of Follow-up of Risedronate (NE-58095) in Postmenopausal Osteoporosis

Parathyroid hormone in the treatment of involutional osteoporosis: Back to the future

Contact Info

Product

Resources

About