Dose-response study of alendronate sodium for the treatment of cancer-associated hypercalcemia.

1993 ◽  
Vol 11 (8) ◽  
pp. 1618-1623 ◽  
Author(s):  
S R Nussbaum ◽  
R P Warrell ◽  
R Rude ◽  
J Glusman ◽  
J P Bilezikian ◽  
...  
Keyword(s):  
Serum Calcium ◽  
Dose Response ◽  
Initial Response ◽  
Complete Response ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Alendronate Sodium ◽  
Double Blind ◽  
Days Of Therapy ◽  
Significant Difference

PURPOSE A randomized, double-blind, dose-ranging study of single-dose intravenous (IV) therapy with alendronate sodium (aminohydroxybutylidene bisphosphonate) was performed in patients with cancer-associated hypercalcemia. PATIENTS AND METHODS Patients with hypercalcemia who had not received antitumor therapy in the preceding 7 days were treated with 48 hours of IV hydration. Patients with persistent hypercalcemia (albumin-corrected serum calcium concentration [CSCC] > or = 11.5 mg/dL) were randomly assigned to receive 2.5, 5, 10, or 15 mg of alendronate infused over 2 hours, or 10 mg of alendronate infused over 24 hours. Fifty-nine patients were treated and 50 patients were assessable for the dose-response relationship. RESULTS Normalization of CSCC (< or = 10.5 mg/dL) was achieved in 22%, 82%, 75%, and 90% of assessable patients in the 2.5-, 5-, 10- (2- and 24-hour groups pooled), and 15-mg dose groups, respectively, within 8 days of therapy. Doses > or = 5 mg were significantly superior to the 2.5-mg dose level (P < .05). There was no significant difference in the minimum CSCC achieved between the 2- and 24-hour infusions of the 10-mg dose. Based on an intent-to-treat analysis of all randomized patients, the overall complete response rate was 74% for dose levels greater than 2.5 mg. For assessable patients who responded to > or = 5 mg of alendronate, the estimated median duration of normocalcemia was 10 days (range, 1 to 25). The estimated median time to relapse (CSCC > 11.5 mg/dL) was 15 days from initial treatment and 12 days from initial response, respectively. Adverse events included a transient febrile response in 34% of patients and eight episodes of reversible elevations in serum transaminase levels among treated patients. CONCLUSION While a statistically significant dose-response relationship was not clearly evident at doses greater than 5 mg, single doses of > or = 5 mg alendronate sodium effectively lowered serum calcium concentrations and were well tolerated in the treatment of cancer-associated hypercalcemia.

Double-blind evaluation of the dose-response relationship of amlodipine in essential hypertension

1993 ◽  
Vol 125 (6) ◽  
pp. 1704-1710 ◽  
Author(s):  
Jawahar L. Mehta ◽  
Larry M. Lopez ◽  
Nicholas D. Vlachakis ◽  
Alan H. Gradman ◽  
David T. Nash ◽  
...  
Keyword(s):  
Essential Hypertension ◽  
Dose Response ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Double Blind ◽  
Relationship Of

scholarly journals Dose-response relationship between higher serum calcium level and higher prevalence of hyperuricemia

Medicine ◽  
2019 ◽  
Vol 98 (20) ◽  
pp. e15611
Author(s):  
Zhichen Liu ◽  
Xiang Ding ◽  
Jing Wu ◽  
Hongyi He ◽  
Ziying Wu ◽  
...  
Keyword(s):  
Serum Calcium ◽  
Dose Response ◽  
Calcium Level ◽  
Serum Calcium Level ◽  
Response Relationship ◽  
Dose Response Relationship

Pharmacodynamics and Dose-Response Relationship of Famotidine: A Double-Blind Randomized Placebo-Controlled Trial

1993 ◽  
Vol 33 (7) ◽  
pp. 636-639 ◽  
Author(s):  
Oscar L. Laskin ◽  
Patricia M. Patterson ◽  
Sumiko Shingo ◽  
Kenneth C. Lasseter ◽  
E. Cooper Shamblen
Keyword(s):  
Dose Response ◽  
Controlled Trial ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Double Blind ◽  
Relationship Of

Nasal decongestant effect of oxymetazoline in the common cold: An objective dose-response study in 106 patients

1989 ◽  
Vol 103 (8) ◽  
pp. 743-746 ◽  
Author(s):  
Anders Åkerland ◽  
Thorsten Klint ◽  
Lars Olén ◽  
Hans Rundcrantz
Keyword(s):  
Clinical Trial ◽  
Dose Response ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Double Blind ◽  
Nasal Decongestant ◽  
Double Blind Clinical Trial ◽  
Symptom Scores ◽  
The Common ◽  
Dose Response Study

AbstractOxymetazoline has been used as decongesting nosedrops for more than 25 years but so far no objective does-response study of the drug has been published. In this double-blind clinical trial the decongestant effect on the nasal mucosa by the doses and concentrations traditionally used of oxymetazoline were studied.In 106 men with acute infectious rhinitis, a significant dose-response relationship was found when the decongestant effect was measured objectively by anterior rhinomanometry and subjectively by symptom scores.The concentration and volumes of the drug recommended from clinical experience seem to be adequate.

Ovine (o) and human (h) corticotrophin releasing factor (CRF) in man: CRF-stimulation and CRF-immunoreactivity

1984 ◽  
Vol 106 (3) ◽  
pp. 289-297 ◽  
Author(s):  
G. K. Stalla ◽  
Johanna Hartwimmer ◽  
K. von Werder ◽  
O. A. Müller
Keyword(s):  
Dose Response ◽  
Biological Response ◽  
Cross Reactivity ◽  
Cortisol Secretion ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Sephadex Column ◽  
Corticotrophin Releasing Factor ◽  
Significant Difference ◽  
Human Material

Abstract. The biological activity of ovine (o) and human (h) corticotrophin releasing factor (CRF) in normal volunteers was investigated. Nine subjects received an iv bolus injection of 50, 100 and 200 μg oCRF. There was no dose-response relationship between the injected oCRF dosage and stimulated ACTH, β-endorphin, and cortisol secretion. The addition of glycine as a stabilizer to 50 and 100 μg oCRF had no effect on stimulated ACTH and cortisol secretion. When 50 and 100 μg hCRF were injected into the same subjects no significant difference compared to the oCRF induced ACTH-response was observed. In contrast to the lacking relationship between the CRF dosage and the biological response there was a clearcut dose-response relationship between the amount of oCRF injected and CRF-immunoreactivity 15 min after injection measured with a specific oCRF radioimmunoassay. Though there was only 10% cross-reactivity with synthetic hCRF, endogenous CRF-immunoreactivity could be detected in 53 of 55 pregnant females and in placental extracts. The fact that endogenous CRF immunoreactivity in humans measured by the oCRF-system may be due to the CRF molecule could be supported by identical elution profiles of synthetic and endogenous hCRF which eluted less retarded than oCRF from the Sephadex column. Our data suggest that the already established stimulation-test with oCRF can be replaced in the future by a test using human material in an identical dosage. In addition determination of endogenous CRF seems to be feasible, particularly with the homologous human system and may be of use in evaluation of patients with pituitary adrenal diseases.

Retrospective Matched Cohort Study of Immune Thrombocytopenic Purpura (ITP): Complications Related to Corticosteroid (CS) Use.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3295-3295
Author(s):  
Louis M. Aledort ◽  
Roger M. Lyons ◽  
Gary Okano ◽  
Joseph Leveque
Keyword(s):  
Logistic Regression ◽  
Dose Response ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Age And Gender ◽  
Event Risk ◽  
Complication Risk ◽  
Days Of Therapy ◽  
And Gender ◽  
Anxiety Depression

Abstract Introduction: ITP is a serious, chronic platelet production/destruction disorder frequently treated with CS (with a 50–70% response rate). While CS-associated adverse events are known to impair health-related quality of life, other disease complications have not been well studied in ITP patients (pts). Methods: A retrospective claims analysis used the PharMetrics Integrated Medical and Pharmaceutical Database (diagnosis, treatment, and claims data from >45 million managed care pts) to compare risks of disease complications in ITP pts (primary thrombocytopenia, ICD-9=287.3 [n=2454; 618 used CS; 1,836 did not]) and age- and gender-matched non-ITP controls (n= 21,196; 2,861 used CS; 18,335 did not) enrolled from July 2000 to December 2003. Incidence (new events during study period/persons exposed to risk) of osteoporosis, diabetes mellitus (DM), fractures, anxiety/depression, hepatitis C, myocardial infarction (MI), gastrointestinal (GI) bleeds, hypertension (HTN), obesity, atrial fibrillation, pancreatitis, cataracts, and stroke were compared between the 2 cohorts through December 2004. Descriptive statistics and univariate and multivariate logistic regression models assessed CS use by 4 measures (number of treatments, average daily dose, days of therapy, continuous duration). Clinical complexity was measured by the Charlson Comorbidity Index. Results: The most common events in ITP pts were HTN, anxiety/depression, DM, osteoporosis, obesity, cataracts, and MI (range, 26 [MI] to 237 [HTN] per 1,000 patient-years). These events were common but less frequent in non-ITP pts. ITP pts had significantly more CS use than non-ITP pts (by 4 treatment measures; all P<0.0001). In ITP pts, incidences of DM, obesity, and GI bleeds (59 vs 30, 42 vs 20, and 16 vs 7/1,000 person-years, respectively) were twice as high in CS users as in nonusers. MIs (20 vs 6/1,000 person-years) were 3 times higher in CS users. Events increased in ITP CS users with number of CS treatments, suggesting a ‘dose-response’ relationship. A similar but less pronounced trend occurred in CS users without ITP. ITP pts receiving >4 CS doses had increased risks of most events (greatest for DM, obesity, and MI; less for osteoporosis, HTN, and depression). Event risk in non-ITP pts did not increase significantly with number of CS prescriptions. Each additional day of CS therapy was associated with a 0.5% increase in risk of osteoporosis, HTN, DM, and anxiety/depression in ITP pts. Osteoporosis, DM, and HTN were more than twice as likely to develop in ITP pts receiving ≥60 days of CS therapy vs those treated for <60 days. In non-ITP pts, days of therapy and event incidence were unrelated. Logistic regression modeling in the ITP population showed that each additional CS treatment carried a 14% increase in the risk of osteoporosis and MI; a 12% increase in the risk of DM and HTN; an 11% increase in the risk of obesity; and a 7% increase in the risk of anxiety/depression (for which non-ITP pts also showed an association). Conclusions: Based on this analysis, ITP pts are at greater complication risk than age- and gender-matched non-ITP pts. CS treatment is consistently associated with increased risks of osteoporosis, DM, and HTN in ITP pts, suggesting added caution regarding CS use. A CS dose-response relationship with event risk is evident in ITP and non-ITP pts. Additional analyses are planned using other data sources to confirm these findings.

scholarly journals Galacto-oligosaccharides increase calcium absorption and gut bifidobacteria in young girls: a double-blind cross-over trial

2013 ◽  
Vol 110 (7) ◽  
pp. 1292-1303 ◽  
Author(s):  
Corrie M. Whisner ◽  
Berdine R. Martin ◽  
Margriet H. C. Schoterman ◽  
Cindy H. Nakatsu ◽  
Linda D. McCabe ◽  
...  
Keyword(s):  
Dose Response ◽  
Denaturing Gradient Gel Electrophoresis ◽  
Calcium Absorption ◽  
Random Order ◽  
Response Relationship ◽  
Dose Response Relationship ◽  
Daily Consumption ◽  
Double Blind ◽  
Gradient Gel Electrophoresis ◽  
High Doses

Adolescence is a time for rapid growth that represents an opportunity to influence peak bone mass. Prebiotic agents, such as galacto-oligosaccharides (GOS), increase Ca absorption in animal models and postmenopausal women. The objectives of the present study were to investigate the dose–response relationship of GOS supplementation on Ca absorption during growth and to assess changes in colonic microbiota to better understand the mechanism by which GOS is acting. A total of thirty-one healthy adolescent girls aged 10–13 years consumed smoothie drinks twice daily with 0, 2·5 or 5 g GOS for three 3-week periods in a random order. Fractional Ca absorption was determined from urinary Ca excretion over 48 h at the end of each 3-week period using a dual stable isotope method. Faecal microbiota and bifidobacteria were assessed by PCR–denaturing gradient gel electrophoresis and quantitative PCR. Fractional Ca absorption after the 48 h treatment with control, 5 and 10 g GOS/d was 0·393 (sd 0·092), 0·444 (sd 0·086) and 0·419 (sd 0·099), respectively. Significant improvements in Ca absorption were seen with both low and high doses of GOS compared with the control (P< 0·02), but it was not a dose–response relationship. The increase in absorption was greatest in the urine collected after 24 h, which is consistent with lower gut absorption. Faecal bifidobacteria increased (control 10·89 (sd 13·86), 5 g GOS 22·80 (sd 15·74) and 10 g GOS 11·54 (sd 14·20)) with the GOS treatment (P< 0·03). The results suggest that daily consumption of 5 g GOS increases Ca absorption, which may be mediated by the gut microbiota, specifically bifidobacteria.

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