* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Monday, July 21, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    12 ‘Late Show’ Moments Proving Stephen Colbert Can’t Be Replaced – The Mountaineer

    12 Unforgettable ‘Late Show’ Moments That Prove Stephen Colbert Is Truly One of a Kind

    Canes owner Tom Dundon’s real estate firm eyes entertainment complex near RDU – The Business Journals

    Canes Owner Tom Dundon’s Real Estate Firm Unveils Plans for Thrilling New Entertainment Complex Near RDU

    Inspired Entertainment, Inc.’s (NASDAQ:INSE) Price Is Right But Growth Is Lacking After Shares Rocket 29% – simplywall.st

    Inspired Entertainment Soars 29% but Growth Momentum Falls Short

    Kroger shares summer entertainment tips – Supermarket Perimeter

    Ultimate Summer Entertainment Tips to Make Your Season Unforgettable

    Theater at Santa Fe’s San Isidro Plaza will be converted into IMAX, family entertainment venue – Santa Fe New Mexican

    Santa Fe’s San Isidro Plaza Theater Transforms into Exciting IMAX Family Entertainment Venue

    B&B Theatres will open massive entertainment complex in Texas – The Business Journals

    B&B Theatres will open massive entertainment complex in Texas – The Business Journals

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology

    Defence Holdings PLC Transitions from Esports to Pioneering Defence Technology

    Bull of the Day: Credo Technology Group (CRDO) – Yahoo Finance

    Bull of the Day: Why Credo Technology Group (CRDO) Is Poised for a Breakout

    BlackSky Technology Inc. Stock Analysis and Forecast – Explosive wealth accumulation – Jammu Links News

    BlackSky Technology Inc.: Unlocking Explosive Wealth Potential Through Expert Stock Analysis and Forecast

    Polypurine Hairpin Technology is Safe, Effective at Inhibiting PCSK9 to Regulate Cholesterol – Pharmacy Times

    Polypurine Hairpin Technology: A Safe and Powerful Breakthrough for Controlling Cholesterol by Targeting PCSK9

    A major AI training data set contains millions of examples of personal data – MIT Technology Review

    A major AI training data set contains millions of examples of personal data – MIT Technology Review

    Simpson College to purchase medical simulation technology with grant funds – Iowa Capital Dispatch

    Simpson College to purchase medical simulation technology with grant funds – Iowa Capital Dispatch

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    12 ‘Late Show’ Moments Proving Stephen Colbert Can’t Be Replaced – The Mountaineer

    12 Unforgettable ‘Late Show’ Moments That Prove Stephen Colbert Is Truly One of a Kind

    Canes owner Tom Dundon’s real estate firm eyes entertainment complex near RDU – The Business Journals

    Canes Owner Tom Dundon’s Real Estate Firm Unveils Plans for Thrilling New Entertainment Complex Near RDU

    Inspired Entertainment, Inc.’s (NASDAQ:INSE) Price Is Right But Growth Is Lacking After Shares Rocket 29% – simplywall.st

    Inspired Entertainment Soars 29% but Growth Momentum Falls Short

    Kroger shares summer entertainment tips – Supermarket Perimeter

    Ultimate Summer Entertainment Tips to Make Your Season Unforgettable

    Theater at Santa Fe’s San Isidro Plaza will be converted into IMAX, family entertainment venue – Santa Fe New Mexican

    Santa Fe’s San Isidro Plaza Theater Transforms into Exciting IMAX Family Entertainment Venue

    B&B Theatres will open massive entertainment complex in Texas – The Business Journals

    B&B Theatres will open massive entertainment complex in Texas – The Business Journals

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology

    Defence Holdings PLC Transitions from Esports to Pioneering Defence Technology

    Bull of the Day: Credo Technology Group (CRDO) – Yahoo Finance

    Bull of the Day: Why Credo Technology Group (CRDO) Is Poised for a Breakout

    BlackSky Technology Inc. Stock Analysis and Forecast – Explosive wealth accumulation – Jammu Links News

    BlackSky Technology Inc.: Unlocking Explosive Wealth Potential Through Expert Stock Analysis and Forecast

    Polypurine Hairpin Technology is Safe, Effective at Inhibiting PCSK9 to Regulate Cholesterol – Pharmacy Times

    Polypurine Hairpin Technology: A Safe and Powerful Breakthrough for Controlling Cholesterol by Targeting PCSK9

    A major AI training data set contains millions of examples of personal data – MIT Technology Review

    A major AI training data set contains millions of examples of personal data – MIT Technology Review

    Simpson College to purchase medical simulation technology with grant funds – Iowa Capital Dispatch

    Simpson College to purchase medical simulation technology with grant funds – Iowa Capital Dispatch

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Health

Calcium Levels Quickly Become Critical for Many Denosumab-Treated Women on Dialysis

January 19, 2024
in Health
Calcium Levels Quickly Become Critical for Many Denosumab-Treated Women on Dialysis
Share on FacebookShare on Twitter

Many women on dialysis quickly developed severe hypocalcemia after starting denosumab (Prolia) for osteoporosis, Medicare data showed.

During the first 12 weeks of treatment, 41.1% of women on denosumab developed severe hypocalcemia compared with 2.0% of those taking oral bisphosphonates, reported a group of largely FDA researchers led by Steven Bird, PhD, PharmD, of the agency offices in Silver Spring, Maryland.

This translated to more than a 20-times higher risk for incident severe hypocalcemia with denosumab (weighted risk ratio 20.7, 95% CI 13.2-41.2), according to the retrospective cohort study in JAMA.

Supported by these new findings, the FDA on Friday added a boxed warning over the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD) taking denosumab for osteoporosis.

The study revealed a sharp decline in calcium levels within the first week of denosumab administration that continued for up to 10 weeks after.

The same was seen in regards to the 12-week weighted cumulative incidence of very severe hypocalcemia, which occurred in 10.9% of denosumab-treated patients versus only 0.4% of those on oral bisphosphonates (weighted RR 26.4, 95% CI 9.7-449.5).

“Stable serum calcium levels observed in this cohort during the 6 months prior to denosumab administration, coupled with the rapid onset and high incidence of severe hypocalcemia post administration, suggest that this association might be causal,” they posited. Because of this, the authors said denosumab should only be administered “after careful patients selection and with plans for frequent monitoring.”

“This may be due to a confluence of nephrology practice patterns, inadequate communication between physicians, and lack of guidance on osteoporosis management in patients undergoing dialysis,” commented accompanying editorial authors Pascale Khairallah, MD, of Baylor College of Medicine in Houston, and Thomas Nickolas, MD, MS, of Columbia University Irving Medical Center in New York.

These findings also weren’t totally unexpected, Khairallah and Nickolas said, as other global studies reported rates of denosumab-related hypocalcemia of up to 42%.

“The lack of guidance on managing osteoporosis in CKD is shared between the nephrology community and drug regulatory agencies,” the editorialists argued. “The broad range of anti-fracture medications being used in patients and the emerging postmarketing adverse event data should prompt medical societies, in conjunction with the … FDA, to produce relevant guidance on management strategies, including restrictions on drug class usage if warranted by drug safety profiles.”

The FDA had issued a safety alert back in November 2022 over denosumab’s potential hypocalcemia risk in dialysis-dependent women. In that safety alert, the agency referred to interim results from maker Amgen’s ongoing safety study of denosumab, which suggested an increased risk of hypocalcemia in patients with advanced kidney disease. That safety study — required upon denosumab’s initial approval — was conducted in men and postmenopausal women with osteoporosis.

Bird’s group looked at Medicare data on women 65 and older who initiated treatment with denosumab 60 mg (n=1,523) or oral bisphosphonates (n=1,281) including alendronate (Fosamax), risedronate (Actonel, Atelvia), or ibandronate (Boniva) from 2013 through 2020. All women were undergoing long-term hemodialysis or peritoneal dialysis and had a diagnosis of osteoporosis or were receiving treatment for low bone mass after therapy with aromatase inhibitors, gonadotropin-releasing hormone agonists, or high-intensity glucocorticoids. Nearly all had osteoporosis and hyperparathyroidism.

The vast majority of these drugs were prescribed by primary care clinicians, followed by endocrinologists and rheumatologists. Less than 3% of scripts were written by nephrologists.

Severe hypocalcemia was defined as total albumin-corrected serum calcium below 7.5 mg/dL (1.88 mmol/L) or a primary hospital or emergency department hypocalcemia diagnosis, while very severe hypocalcemia was considered a serum calcium below 6.5 mg/dL (1.63 mmol/L) or emergent care. Almost all severe hypocalcemia cases were identified based on albumin-corrected serum calcium levels rather than based on emergency department or hospital diagnosis.

author['full_name']

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.

Disclosures

The study was funded by the FDA through an interagency agreement with the Centers for Medicare & Medicaid Services.

Bird and co-authors reported employment with the FDA and relationships with Acumen, which is the contractor for this study’s interagency funding agreement between the FDA and the Centers for Medicare & Medicaid Services.

Nickolas reported grants from Amgen and scientific advisory board membership for Pharmacosmos.

Khairallah disclosed no relevant relationships with industry.

Primary Source

JAMA

Source Reference: Bird ST, et al “Severe hypocalcemia with denosumab among older female dialysis-dependent patients” JAMA 2024; DOI: 10.1001/jama.2023.28239.

Secondary Source

JAMA

Source Reference: Khairallah P, Nickolas TL “Managing osteoporosis in dialysis — a medical Catch-22” JAMA 2024; DOI: 10.1001/jama.2023.24072.

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : MedPageToday – https://www.medpagetoday.com/endocrinology/osteoporosis/108328

Tags: Calciumhealthlevels
Previous Post

Newborns Better Protected With 3 Doses of Maternal COVID Vaccine

Next Post

MedPod Today: Residency Application Updates; Doc Discipline; Vacation and Burnout

Defence Holdings PLC Transitions from Esports to Pioneering Defence Technology

July 21, 2025
Fanatics aided criminal investigation into sports memorabilia dealer. The dealer was later found dead. – The Athletic – The New York Times

Fanatics Helped Crack Sports Memorabilia Case Before Dealer’s Mysterious Death

July 21, 2025
Architecture Students’ Project Selected for Royal Academy Exhibition – Syracuse University News

Syracuse Architecture Students Selected for Prestigious Royal Academy Exhibition

July 21, 2025
Health experts raise alarm over RFK Jr’s ‘war on science’ amid mass firings and budget cuts – The Guardian

Health Experts Sound the Alarm on RFK Jr’s ‘War on Science’ Amid Mass Firings and Budget Cuts

July 21, 2025
Do dogs know who’s kind? Scientists put it to the test—and got a surprise – ScienceDaily

Do dogs know who’s kind? Scientists put it to the test—and got a surprise – ScienceDaily

July 21, 2025
Making these lifestyle changes reduces chronic disease, even if you have a genetic risk – WPBF

Transform Your Health: Simple Lifestyle Changes That Slash Chronic Disease Risk-Even If It Runs in Your Genes

July 21, 2025
Win a VIP trip to Tokyo – worldathletics.org

Win an Exclusive VIP Trip to Tokyo – Enter Now for Your Chance!

July 21, 2025
Under Governor Shapiro, Pennsylvania is a National Leader in Economic Growth, AI Innovation, and Energy – PA Department of Community & Economic Development (.gov)

Under Governor Shapiro, Pennsylvania is a National Leader in Economic Growth, AI Innovation, and Energy – PA Department of Community & Economic Development (.gov)

July 21, 2025
12 ‘Late Show’ Moments Proving Stephen Colbert Can’t Be Replaced – The Mountaineer

12 Unforgettable ‘Late Show’ Moments That Prove Stephen Colbert Is Truly One of a Kind

July 21, 2025
AI in health care could save lives and money — but not yet – PBS

AI in health care could save lives and money — but not yet – PBS

July 21, 2025

Categories

Archives

July 2025
MTWTFSS
 123456
78910111213
14151617181920
21222324252627
28293031 
« Jun    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (731)
  • Economy (754)
  • Entertainment (21,639)
  • General (16,014)
  • Health (9,792)
  • Lifestyle (762)
  • News (22,149)
  • People (756)
  • Politics (763)
  • Science (15,971)
  • Sports (21,252)
  • Technology (15,737)
  • World (737)

Recent News

Defence Holdings PLC Transitions from Esports to Pioneering Defence Technology

July 21, 2025
Fanatics aided criminal investigation into sports memorabilia dealer. The dealer was later found dead. – The Athletic – The New York Times

Fanatics Helped Crack Sports Memorabilia Case Before Dealer’s Mysterious Death

July 21, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version